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A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy (OAK)

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ClinicalTrials.gov Identifier: NCT02008227
Recruitment Status : Completed
First Posted : December 11, 2013
Results First Posted : July 2, 2017
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Squamous Non-Small Cell Lung Cancer
Interventions Drug: Atezolizumab
Drug: Docetaxel
Enrollment 1225
Recruitment Details  
Pre-assignment Details Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Period Title: Overall Study
Started 612 613
Treated 579 608
Completed 0 0
Not Completed 612 613
Reason Not Completed
Lost to Follow-up             7             9
Death             494             485
Withdrawal by Subject             67             36
Study Terminated By Sponsor             44             83
Arm/Group Title Docetaxel Atezolizumab Total
Hide Arm/Group Description Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 612 613 1225
Hide Baseline Analysis Population Description
SP-Intent to Treat (ITT) analysis set included all randomized ITT participants regardless of whether they received any study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 612 participants 613 participants 1225 participants
62.9  (9.2) 62.7  (9.8) 62.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 613 participants 1225 participants
Female
233
  38.1%
234
  38.2%
467
  38.1%
Male
379
  61.9%
379
  61.8%
758
  61.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 613 participants 1225 participants
Hispanic or Latino
42
   6.9%
48
   7.8%
90
   7.3%
Not Hispanic or Latino
541
  88.4%
540
  88.1%
1081
  88.2%
Unknown or Not Reported
29
   4.7%
25
   4.1%
54
   4.4%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
American Indian or Alaska Native Number Analyzed 2 participants 1 participants 3 participants
2 1 3
Asian Number Analyzed 125 participants 124 participants 249 participants
125 124 249
Black or African American Number Analyzed 16 participants 11 participants 27 participants
16 11 27
Native Hawaiian or other Pacific Islander Number Analyzed 2 participants 3 participants 5 participants
2 3 5
White Number Analyzed 432 participants 438 participants 870 participants
432 438 870
Other Number Analyzed 12 participants 11 participants 23 participants
12 11 23
Multiple Number Analyzed 1 participants 2 participants 3 participants
1 2 3
Unknown Number Analyzed 22 participants 23 participants 45 participants
22 23 45
[1]
Measure Analysis Population Description: SP-ITT Population
1.Primary Outcome
Title Percentage of Participants Who Died: PP-ITT
Hide Description [Not Specified]
Time Frame Baseline until death due to any cause (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Measure Type: Number
Unit of Measure: Percentage of Participants
70.1 63.8
2.Primary Outcome
Title Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Hide Description Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
Time Frame Baseline until death due to any cause (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 222 241
Measure Type: Number
Unit of Measure: Percentage of Participants
67.1 62.7
3.Primary Outcome
Title Overall Survival (OS): PP-ITT
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death due to any cause (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Median (95% Confidence Interval)
Unit of Measure: Months
9.6
(8.6 to 11.2)
13.8
(11.8 to 15.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.62 to 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.62 to 0.86
Estimation Comments [Not Specified]
4.Primary Outcome
Title OS: TC1/2/3 or IC1/2/3 Subgroup of PP
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death due to any cause (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC1/2/3 or IC1/2/3 subgroup of PP
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 222 241
Median (95% Confidence Interval)
Unit of Measure: Months
10.3
(8.8 to 12.0)
15.7
(12.6 to 18.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0102
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.58 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.58 to 0.91
Estimation Comments [Not Specified]
5.Primary Outcome
Title OS: SP-ITT
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death due to any cause (up to approximately 2.87 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 612 613
Median (95% Confidence Interval)
Unit of Measure: Months
9.8
(8.8 to 11.3)
13.3
(11.3 to 14.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.70 to 0.92
Estimation Comments [Not Specified]
6.Primary Outcome
Title OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death from any cause (approximately 2.87 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC1/2/3 Or IC1/2/3 Subgroup of SP.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 337 347
Median (95% Confidence Interval)
Unit of Measure: Months
10.8
(9.3 to 12.0)
14.3
(12.4 to 16.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.64 to 0.92
Estimation Comments [Not Specified]
7.Primary Outcome
Title OS: TC2/3 or IC2/3 Subgroup of SP
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death due to any cause (up to approximately 2.87 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC2/3 or IC2/3 Subgroup of SP.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 182 168
Median (95% Confidence Interval)
Unit of Measure: Months
11.4
(9.3 to 12.9)
16.6
(13.6 to 20.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.49 to 0.84
Estimation Comments [Not Specified]
8.Primary Outcome
Title OS: TC3 or IC3 Subgroup of SP
Hide Description OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame Baseline until death due to any cause (up to approximately 2.87 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC3 or IC3 Subgroup of SP.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 85 89
Median (95% Confidence Interval)
Unit of Measure: Months
9.7
(7.9 to 11.6)
20.5
(16.8 to 30.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.30 to 0.68
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
Hide Description PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
Time Frame Baseline up to PD or Death (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Measure Type: Number
Unit of Measure: Percentage of Participants
88.2 89.4
10.Secondary Outcome
Title Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
Hide Description PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame Baseline up to PD or Death (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
TC1/2/3 or IC1/2/3 subgroup of PP
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 222 241
Measure Type: Number
Unit of Measure: Percentage of Participants
86.9 89.6
11.Secondary Outcome
Title Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
Hide Description PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Median (95% Confidence Interval)
Unit of Measure: Months
4.0
(3.3 to 4.2)
2.8
(2.6 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4928
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.82 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3596
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.81 to 1.08
Estimation Comments [Not Specified]
12.Secondary Outcome
Title PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Hide Description PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The TC1/2/3 or IC1/2/3 subgroup of PP
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 222 241
Median (95% Confidence Interval)
Unit of Measure: Months
4.1
(2.9 to 4.3)
2.8
(2.6 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3806
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.74 to 1.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3249
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.74 to 1.10
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Hide Description Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
13.4
(10.32 to 17.02)
13.6
(10.53 to 17.28)
14.Secondary Outcome
Title Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Hide Description Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
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Hide Analysis Population Description
The TC1/2/3 or IC1/2/3 subgroup of PP
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 222 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
16.2
(11.62 to 21.74)
17.8
(13.22 to 23.27)
15.Secondary Outcome
Title Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
Hide Description DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 57 58
Median (95% Confidence Interval)
Unit of Measure: Months
6.2
(4.9 to 7.6)
16.3 [1] 
(10.0 to NA)
[1]
Data not reported because the upper limit of confidence interval (CI) was not estimable due to higher number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.18 to 0.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.21 to 0.55
Estimation Comments [Not Specified]
16.Secondary Outcome
Title DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Hide Description DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The TC1/2/3 or IC1/2/3 subgroup of PP
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 36 43
Median (95% Confidence Interval)
Unit of Measure: Months
6.2
(4.9 to 9.2)
16.0 [1] 
(9.7 to NA)
[1]
Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.31
Confidence Interval (2-Sided) 95%
0.15 to 0.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.22 to 0.65
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Hide Description [Not Specified]
Time Frame Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
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Hide Analysis Population Description
ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 565
Measure Type: Number
Unit of Measure: Percentage of Participants
30.4
18.Secondary Outcome
Title Maximum Observed Serum Atezolizumab Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
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Hide Analysis Population Description
Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 606
Mean (Standard Deviation)
Unit of Measure: Microgram per milliliter (mcg/mL)
400  (127)
19.Secondary Outcome
Title Minimum Observed Serum Atezolizumab Concentration (Cmin)
Hide Description [Not Specified]
Time Frame Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
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Hide Analysis Population Description
PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Atezolizumab
Hide Arm/Group Description:
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 606
Mean (Standard Deviation)
Unit of Measure: mcg/mL
C1D1 (n= 593) 2.59  (30.9)
C2D1 (n= 534) 83.2  (31.0)
C3D1 (n= 445) 130  (55.8)
C4D1 (n= 405) 158  (66.4)
C8D1 (n= 222) 205  (99.4)
C16D1 (n= 132) 226  (105)
C24D1 (n= 63) 250  (99.8)
C32D1 (n= 11) 277  (117)
EOT (n= 347) 144  (101)
120 days after EOT (n= 124) 10.4  (20.0)
20.Secondary Outcome
Title Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Hide Description TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
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Hide Analysis Population Description
The PP-ITT analysis set.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Median (95% Confidence Interval)
Unit of Measure: Months
Pain in Chest
8.3
(4.6 to 12.5)
18.0 [1] 
(11.0 to NA)
Cough
5.6
(4.0 to 12.8)
5.5
(4.2 to 7.9)
Dyspnea
2.1
(1.6 to 2.3)
1.8
(1.5 to 2.3)
Arm/Shoulder Pain
6.2
(4.9 to 14.7)
8.3
(5.8 to 12.8)
[1]
Data not reported because the upper limit of CI was not estimable due to higher number of censored participants.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0111
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.55 to 0.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Cough: Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6305
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.84 to 1.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Dyspnea: Unstratified Analysis
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7406
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.81 to 1.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Docetaxel, Atezolizumab
Comments Arm/Shoulder Pain
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5221
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.73 to 1.17
Estimation Comments [Not Specified]
21.Secondary Outcome
Title EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Hide Description EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Appetite Loss: Baseline (n= 390, 413) 26.58  (31.57) 22.92  (29.41)
Appetite Loss: Cycle (C) 2 Day (D) 1(n= 342, 368) 27.49  (30.39) 26.99  (31.16)
Appetite Loss: C3D1(n= 256, 304) 21.35  (28.84) 21.16  (28.94)
Appetite Loss: C4D1(n= 224, 279) 18.75  (25.36) 18.40  (26.60)
Appetite Loss: C5D1(n= 166, 238) 18.88  (23.89) 16.67  (27.52)
Appetite Loss: C6D1(n= 151, 224) 18.98  (25.68) 14.88  (25.39)
Appetite Loss: C7D1(n= 88, 190) 15.91  (24.75) 12.46  (23.06)
Appetite Loss: C8D1(n= 72, 170) 13.89  (22.20) 12.94  (23.27)
Appetite Loss: C9D1(n= 50, 153) 8.00  (18.52) 11.33  (22.35)
Appetite Loss: C10D1(n= 47, 146) 7.80  (15.87) 12.33  (21.45)
Appetite Loss: C11D1(n= 37, 134) 11.71  (23.85) 11.44  (22.43)
Appetite Loss: C12D1(n= 30, 132) 11.11  (20.22) 8.84  (18.81)
Appetite Loss: C13D1(n= 19, 123) 10.53  (15.92) 8.40  (15.74)
Appetite Loss: C14D1(n= 18, 120) 7.41  (14.26) 10.00  (17.61)
Appetite Loss: C15D1(n= 16, 113) 6.25  (13.44) 12.39  (22.80)
Appetite Loss: C16D1(n= 13, 109) 7.69  (14.62) 10.09  (19.51)
Appetite Loss: C17D1(n= 11, 98) 6.06  (13.48) 7.82  (18.41)
Appetite Loss: C18D1(n= 10, 91) 6.67  (14.05) 8.06  (18.15)
Appetite Loss: C19D1(n= 9, 84) 7.41  (14.70) 9.13  (18.18)
Appetite Loss: C20D1(n= 9, 80) 11.11  (23.57) 9.58  (21.34)
Appetite Loss: C21D1(n= 9, 75) 3.70  (11.11) 12.44  (26.15)
Appetite Loss: C22D1(n= 8, 69) 8.33  (15.43) 6.76  (16.74)
Appetite Loss: C23D1(n= 8, 66) 8.33  (15.43) 7.58  (17.34)
Appetite Loss: C24D1(n= 5, 64) 13.33  (18.26) 8.33  (15.71)
Appetite Loss: C25D1(n= 3, 60) 0.00  (0.00) 6.11  (13.01)
Appetite Loss: C26D1(n= 3, 55) 22.22  (19.24) 5.45  (12.45)
Appetite Loss: C27D1(n= 3, 52) 0.00  (0.00) 9.62  (19.06)
Appetite Loss: C28D1(n= 1, 49) 0.00 [1]   (NA) 7.48  (15.61)
Appetite Loss: C29D1(n= 2, 40) 33.33  (47.14) 9.17  (16.86)
Appetite Loss: C30D1(n= 1, 31) 0.00 [2]   (NA) 1.08  (5.99)
Appetite Loss: C31D1(n= 0, 24) NA [3]   (NA) 6.94  (13.83)
Appetite Loss: C32D1(n= 0, 22) NA [3]   (NA) 7.58  (22.84)
Appetite Loss: C33D1(n= 0,16) NA [3]   (NA) 8.33  (25.82)
Appetite Loss: C34D1(n= 0, 14) NA [3]   (NA) 4.76  (17.82)
Appetite Loss: C35D1(n= 0, 12) NA [3]   (NA) 8.33  (20.72)
Appetite Loss: C36D1(n= 0, 8) NA [3]   (NA) 4.17  (11.78)
Appetite Loss: C37D1(n= 0, 5) NA [3]   (NA) 6.67  (14.91)
Appetite Loss: C38D1(n= 0, 2) NA [3]   (NA) 0.00  (0.00)
Appetite Loss: End of treatment (EOT)(n= 265, 246) 29.81  (31.85) 31.98  (33.51)
Appetite Loss: Pro Week 6 Pd(n= 0,1) NA [3]   (NA) 33.33 [2]   (NA)
Appetite Loss: Survival Follow-up (FU) 1 (n= 2, 1) 50.00  (70.71) 66.67 [2]   (NA)
Constipation: Baseline (n= 388, 410) 19.93  (27.39) 16.50  (26.81)
Constipation: C2D1(n= 339, 363) 19.47  (26.42) 18.09  (26.92)
Constipation: C3D1(n= 255, 304) 19.74  (26.91) 15.13  (23.71)
Constipation: C4D1(n= 224, 277) 17.86  (23.38) 14.56  (23.58)
Constipation: C5D1(n= 166, 236) 13.05  (21.33) 12.15  (21.16)
Constipation: C6D1(n= 151, 225) 14.35  (23.89) 12.89  (22.42)
Constipation: C7D1(n= 87, 188) 13.41  (20.62) 11.52  (21.04)
Constipation: C8D1(n= 72, 171) 8.33  (15.57) 12.28  (21.36)
Constipation: C9D1(n= 50, 153) 9.33  (19.10) 10.68  (17.79)
Constipation: C10D1(n= 47, 146) 9.22  (17.99) 9.82  (17.58)
Constipation: C11D1(n= 37, 134) 5.41  (12.46) 9.95  (17.83)
Constipation: C12D1(n= 30, 132) 11.11  (20.22) 10.86  (18.65)
Constipation: C13D1(n= 19, 124) 5.26  (12.49) 8.60  (15.83)
Constipation: C14D1(n= 17, 121) 15.69  (23.91) 9.09  (16.67)
Constipation: C15D1(n= 15, 113) 2.22  (8.61) 10.03  (17.75)
Constipation: C16D1(n= 13, 109) 20.51  (32.03) 9.79  (18.87)
Constipation: C17D1(n= 11, 98) 12.12  (22.47) 9.86  (19.27)
Constipation: C18D1(n= 10, 92) 6.67  (14.05) 9.06  (17.89)
Constipation: C19D1(n= 9, 83) 7.41  (14.70) 9.64  (18.43)
Constipation: C20D1(n=9, 80) 14.81  (33.79) 12.50  (23.35)
Constipation: C21D1(n= 9, 75) 7.41  (14.70) 14.22  (25.22)
Constipation: C22D1(n= 8, 69) 12.50  (24.80) 11.59  (21.26)
Constipation: C23D1(n= 8, 66) 4.17  (11.78) 10.10  (20.23)
Constipation: C24D1(n=5, 65) 20.00  (29.81) 9.74  (17.40)
Constipation: C25D1(n= 3, 60) 0.00  (0.00) 11.11  (19.08)
Constipation: C26D1(n= 2, 55) 0.00  (0.00) 12.12  (20.65)
Constipation: C27D1(n= 3, 52) 0.00  (0.00) 13.46  (20.09)
Constipation: C28D1(n= 1, 48) 0.00 [2]   (NA) 11.81  (22.27)
Constipation: C29D1(n= 2, 40) 50.00  (70.71) 15.83  (23.86)
Constipation: C30D1(n= 1, 31) 0.00 [2]   (NA) 8.60  (19.18)
Constipation: C31D1(n= 0, 24) NA [3]   (NA) 9.72  (20.80)
Constipation: C32D1(n= 0, 22) NA [3]   (NA) 6.06  (13.16)
Constipation: C33D1(n= 0, 16) NA [3]   (NA) 4.17  (11.39)
Constipation: C34D1(n= 0, 14) NA [3]   (NA) 7.14  (14.19)
Constipation: C35D1(n= 0, 12) NA [3]   (NA) 5.56  (12.97)
Constipation: C36D1(n= 0, 8) NA [3]   (NA) 4.17  (11.78)
Constipation: C37D1(n= 0, 5) NA [3]   (NA) 0.00  (0.00)
Constipation: C38D1(n= 0, 2) NA [3]   (NA) 0.00  (0.00)
Constipation: EOT (n= 265, 246) 19.12  (27.28) 19.78  (28.36)
Constipation: Pro Week 6 Pd(n= 0,1) NA [3]   (NA) 66.67 [2]   (NA)
Constipation: Survival FU-1 (n= 2,1) 33.33  (47.14) 66.67 [2]   (NA)
Diarrhea: Baseline (n= 388, 411) 5.84  (13.77) 7.22  (17.86)
Diarrhea: C2D1(n= 339, 361) 11.21  (20.65) 7.29  (17.72)
Diarrhea: C3D1(n= 255, 304) 10.07  (18.68) 6.14  (15.75)
Diarrhea: C4D1(n= 223, 280) 8.22  (16.35) 6.67  (17.71)
Diarrhea: C5D1(n= 166, 238) 8.43  (17.48) 6.58  (16.16)
Diarrhea: C6D1(n= 151, 222) 7.51  (14.99) 6.31  (14.88)
Diarrhea: C7D1(n= 87, 189) 10.34  (17.10) 7.94  (17.24)
Diarrhea: C8D1(n= 72, 171) 7.41  (15.03) 8.77  (17.56)
Diarrhea: C9D1(n= 50, 153) 11.33  (17.31) 7.63  (16.44)
Diarrhea: C10D1(n= 47, 146) 7.80  (14.27) 5.48  (15.67)
Diarrhea: C11D1(n= 36, 134) 8.33  (14.64) 4.98  (14.46)
Diarrhea: C12D1(n= 30, 132) 10.00  (17.83) 6.31  (16.54)
Diarrhea: C13D1(n= 18, 124) 11.11  (16.17) 5.65  (14.55)
Diarrhea: C14D1(n= 17, 121) 3.92  (11.07) 9.92  (19.07)
Diarrhea: C15D1(n= 15, 113) 8.89  (15.26) 7.96  (17.97)
Diarrhea: C16D1(n= 12, 108) 13.89  (17.16) 6.48  (14.02)
Diarrhea: C17D1(n= 11, 98) 9.09  (15.57) 7.82  (16.44)
Diarrhea: C18D1(n= 10, 92) 13.33  (17.21) 8.70  (17.73)
Diarrhea: C19D1(n= 9, 84) 14.81  (17.57) 7.94  (18.38)
Diarrhea: C20D1(n= 9, 80) 7.41  (14.70) 6.67  (14.43)
Diarrhea: C21D1(n= 9, 75) 18.52  (17.57) 11.11  (18.45)
Diarrhea: C22D1(n= 8, 68) 16.67  (25.20) 7.84  (16.41)
Diarrhea: C23D1(n= 8, 66) 8.33  (15.43) 6.06  (16.44)
Diarrhea: C24D1(n= 5, 64) 6.67  (14.91) 6.25  (16.67)
Diarrhea: C25D1(n= 3, 60) 0.00  (0.00) 6.11  (14.38)
Diarrhea: C26D1(n= 3, 55) 11.11  (19.24) 10.30  (21.15)
Diarrhea: C27D1(n= 3, 52) 11.11  (19.24) 5.77  (15.79)
Diarrhea: C28D1(n= 1, 48) 0.00 [2]   (NA) 4.86  (13.73)
Diarrhea: C29D1(n= 2, 40) 50.00  (70.71) 9.17  (18.47)
Diarrhea: C30D1(n= 1, 31) 0.00 [2]   (NA) 7.53  (16.58)
Diarrhea: C31D1(n= 0, 24) NA [3]   (NA) 6.94  (16.97)
Diarrhea: C32D1(n= 0, 22) NA [3]   (NA) 12.12  (16.41)
Diarrhea: C33D1(n= 0, 16) NA [3]   (NA) 8.33  (14.91)
Diarrhea: C34D1(n= 0, 14) NA [3]   (NA) 4.76  (12.10)
Diarrhea: C35D1(n= 0, 12) NA [3]   (NA) 5.56  (12.97)
Diarrhea: C36D1(n= 0, 8) NA [3]   (NA) 4.17  (11.78)
Diarrhea: C37D1(n= 0, 5) NA [3]   (NA) 6.67  (14.91)
Diarrhea: C38D1(n= 0, 2) NA [3]   (NA) 0.00  (0.00)
Diarrhea: EOT(n= 265, 246) 10.57  (19.18) 9.35  (20.39)
Diarrhea: Pro Week 6 Pd(n= 0, 1) NA [3]   (NA) 0.00 [2]   (NA)
Diarrhea: Survival FU-1 (n= 2, 1) 33.33  (47.14) 33.33 [2]   (NA)
Financial Difficulties: Baseline (n=387, 411) 20.76  (27.61) 18.09  (28.32)
Financial Difficulties: C2D1 (n=336, 362) 18.45  (26.20) 15.93  (26.28)
Financial Difficulties: C3D1 (n=253, 305) 16.86  (24.24) 15.63  (25.79)
Financial Difficulties: C4D1 (n=219, 280) 16.74  (23.97) 15.12  (24.72)
Financial Difficulties: C5D1 (n=165, 238) 16.57  (24.03) 15.13  (25.71)
Financial Difficulties: C6D1 (n=149, 224) 15.66  (24.06) 16.67  (26.41)
Financial Difficulties: C7D1 (n=86, 189) 16.28  (24.92) 17.46  (27.41)
Financial Difficulties: C8D1 (n=71, 170) 13.15  (21.44) 18.82  (27.59)
Financial Difficulties: C9D1 (n=49, 152) 16.33  (28.16) 17.54  (27.38)
Financial Difficulties: C10D1 (n=46, 146) 14.49  (23.99) 17.81  (29.08)
Financial Difficulties: C11D1 (n=36, 134) 9.26  (21.98) 19.65  (30.10)
Financial Difficulties: C12D1 (n=30, 132) 12.22  (23.95) 18.43  (28.92)
Financial Difficulties: C13D1 (n=18, 122) 12.96  (25.92) 18.31  (29.10)
Financial Difficulties: C14D1 (n=17, 121) 15.69  (26.66) 18.46  (29.17)
Financial Difficulties: C15D1 (n=15, 113) 6.67  (18.69) 18.29  (28.86)
Financial Difficulties: C16D1 (n=12, 109) 13.89  (30.01) 18.65  (29.20)
Financial Difficulties: C17D1 (n=11, 98) 15.15  (22.92) 18.37  (27.55)
Financial Difficulties: C18D1 (n=10, 92) 10.00  (22.50) 19.57  (28.45)
Financial Difficulties: C19D1 (n=9, 84) 3.70  (11.11) 19.05  (28.94)
Financial Difficulties: C20D1 (n=9, 80) 11.11  (33.33) 18.75  (27.99)
Financial Difficulties: C21D1 (n=9, 75) 11.11  (33.33) 23.11  (30.99)
Financial Difficulties: C22D1 (n=8, 68) 12.50  (35.36) 18.63  (28.44)
Financial Difficulties: C23D1 (n=7, 66) 9.52  (25.20) 21.72  (30.66)
Financial Difficulties: C24D1 (n=5, 64) 13.33  (29.81) 20.83  (29.99)
Financial Difficulties: C25D1 (n=3, 60) 0.00  (0.00) 21.67  (31.19)
Financial Difficulties: C26D1 (n=3, 55) 0.00  (0.00) 20.00  (30.50)
Financial Difficulties: C27D1 (n=3, 52) 0.00  (0.00) 17.31  (28.38)
Financial Difficulties: C28D1 (n=1, 48) 0.00 [2]   (NA) 18.06  (26.59)
Financial Difficulties: C29D1 (n=2, 40) 50.00  (70.71) 19.17  (28.13)
Financial Difficulties: C30D1 (n=1, 31) 0.00 [2]   (NA) 17.20  (25.63)
Financial Difficulties: C31D1(n=0, 24) NA [3]   (NA) 20.83  (25.66)
Financial Difficulties: C32D1(n=0, 22) NA [3]   (NA) 21.21  (26.32)
Financial Difficulties: C33D1(n=0, 16) NA [3]   (NA) 22.92  (29.11)
Financial Difficulties: C34D1(n=0, 14) NA [3]   (NA) 26.19  (35.03)
Financial Difficulties: C35D1(n=0, 12) NA [3]   (NA) 27.78  (37.15)
Financial Difficulties: C36D1(n=0, 8) NA [3]   (NA) 8.33  (15.43)
Financial Difficulties: C37D1(n=0, 5) NA [3]   (NA) 26.67  (43.46)
Financial Difficulties: C38D1(n=0, 2) NA [3]   (NA) 16.67  (23.57)
Financial Difficulties: EOT(n=263, 245) 21.80  (29.23) 19.46  (28.75)
Financial Difficulties: Pro Week 6 Pd (n=0, 1) NA [3]   (NA) 33.33 [2]   (NA)
Financial Difficulties:Survival FU-1 (n=2,24) 83.33  (23.57) 66.67 [2]   (NA)
Insomnia: Baseline (n= 388, 413) 28.87  (30.55) 26.15  (28.72)
Insomnia: C2D1(n= 340, 367) 27.55  (30.87) 26.52  (28.61)
Insomnia: C3D1(n= 253, 304) 25.69  (29.15) 24.89  (27.32)
Insomnia: C4D1(n= 222, 279) 21.32  (26.07) 23.66  (26.48)
Insomnia: C5D1(n= 166, 237) 21.49  (25.43) 25.88  (29.84)
Insomnia: C6D1(n= 150, 225) 22.00  (26.71) 23.41  (27.73)
Insomnia: C7D1(n= 87, 189) 21.07  (25.47) 23.99  (26.65)
Insomnia: C8D1(n= 70, 169) 15.24  (23.87) 23.87  (26.27)
Insomnia: C9D1(n= 49, 153) 16.33  (26.46) 22.88  (27.16)
Insomnia: C10D1(n= 46, 144) 13.77  (19.34) 21.53  (26.87)
Insomnia: C11D1(n= 36, 133) 9.26  (18.87) 20.55  (27.44)
Insomnia: C12D1(n= 29, 132) 16.09  (30.37) 21.46  (24.41)
Insomnia: C13D1(n= 17, 124) 17.65  (29.15) 23.39  (28.51)
Insomnia: C14D1(n= 17, 121) 25.49  (27.71) 23.69  (26.33)
Insomnia: C15D1(n= 15, 113) 22.22  (29.99) 21.53  (28.84)
Insomnia: C16D1(n= 13, 108) 20.51  (25.60) 21.60  (31.01)
Insomnia: C17D1(n= 11, 98) 21.21  (26.97) 20.07  (28.21)
Insomnia: C18D1(n= 10, 92) 20.00  (32.20) 21.38  (27.77)
Insomnia: C19D1(n= 9, 83) 18.52  (24.22) 22.49  (28.09)
Insomnia: C20D1(n= 9, 80) 18.52  (33.79) 20.83  (29.71)
Insomnia: C21D1(n= 9, 75) 22.22  (33.33) 20.89  (29.90)
Insomnia: C22D1(n= 8, 69) 16.67  (35.63) 18.84  (26.49)
Insomnia: C23D1(n= 8, 66) 20.83  (35.36) 19.70  (28.03)
Insomnia: C24D1(n= 5, 64) 26.67  (27.89) 19.79  (25.00)
Insomnia: C25D1(n= 3, 60) 11.11  (19.24) 18.89  (23.26)
Insomnia: C26D1(n= 3, 55) 11.11  (19.24) 21.21  (27.49)
Insomnia: C27D1(n= 3, 52) 11.11  (19.24) 19.23  (28.27)
Insomnia: C28D1(n= 1, 49) 0.00 [2]   (NA) 21.09  (27.80)
Insomnia: C29D1(n= 2, 40) 33.33  (47.14) 21.67  (26.74)
Insomnia: C30D1(n= 1, 31) 0.00 [2]   (NA) 20.43  (28.12)
Insomnia: C31D1(n= 0, 24) NA [3]   (NA) 20.83  (27.47)
Insomnia: C32D1(n= 0, 22) NA [3]   (NA) 19.70  (26.55)
Insomnia: C33D1(n= 0, 16) NA [3]   (NA) 20.83  (34.16)
Insomnia: C34D1(n= 0, 14) NA [3]   (NA) 23.81  (24.21)
Insomnia: C35D1(n= 0, 12) NA [3]   (NA) 25.00  (28.87)
Insomnia: C36D1(n= 0, 8) NA [3]   (NA) 25.00  (23.57)
Insomnia: C37D1(n= 0, 5) NA [3]   (NA) 33.33  (23.57)
Insomnia: C38D1(n= 0, 2) NA [3]   (NA) 16.67  (23.57)
Insomnia: EOT(n= 264, 246) 28.91  (30.65) 29.95  (30.30)
Insomnia: Pro Week Pd(n= 0, 1) NA [3]   (NA) 66.67 [2]   (NA)
Insomnia: Survival FU-1 (n= 2, 1) 50.00  (70.71) 100.00 [2]   (NA)
Dyspnea: C1D1 (n= 389, 412) 33.50  (31.11) 32.04  (28.73)
Dyspnea: C2D1 (n= 341, 368) 32.55  (29.03) 31.88  (29.70)
Dyspnea: C3D1 (n= 255, 302) 29.93  (27.54) 27.15  (26.73)
Dyspnea: C4D1 (n= 389, 277) 28.38  (24.37) 28.28  (27.48)
Dyspnea: C5D1 (n= 222, 236) 29.52  (24.46) 27.82  (27.03)
Dyspnea: C6D1 (n= 166, 222) 30.02  (26.32) 26.88  (25.63)
Dyspnea: C7D1 (n= 151, 188) 27.13  (25.31) 25.53  (25.99)
Dyspnea: C8D1 (n= 86, 169) 28.70  (29.76) 26.43  (26.70)
Dyspnea: C9D1 (n= 72, 152) 26.67  (28.57) 24.12  (24.92)
Dyspnea: C10D1 (n= 50, 146) 27.66  (28.93) 23.52  (23.54)
Dyspnea: C11D1 (n= 47, 134) 25.23  (30.84) 22.89  (25.00)
Dyspnea: C12D1 (n= 37, 132) 26.67  (26.84) 22.73  (25.83)
Dyspnea: C13D1 (n= 30, 123) 19.30  (23.08) 25.47  (26.68)
Dyspnea: C14D1 (n= 19, 119) 20.37  (25.92) 21.85  (25.47)
Dyspnea: C15D1 (n= 16, 113) 16.67  (17.21) 22.71  (24.51)
Dyspnea: C16D1 (n= 13, 109) 20.51  (16.88) 21.71  (25.00)
Dyspnea: C17D1 (n= 11, 98) 15.15  (17.41) 21.43  (23.57)
Dyspnea: C18D1 (n= 10, 92) 20.00  (17.21) 22.83  (25.64)
Dyspnea: C19D1 (n= 9, 84) 11.11  (16.67) 23.41  (23.59)
Dyspnea: C20D1 (n= 9, 80) 18.52  (17.57) 21.67  (24.36)
Dyspnea: C21D1 (n= 9, 75) 18.52  (17.57) 19.11  (20.63)
Dyspnea: C22D1 (n= 8, 68) 20.83  (35.36) 20.59  (23.06)
Dyspnea: C23D1 (n= 8, 65) 12.50  (17.25) 18.46  (21.27)
Dyspnea: C24D1 (n= 5, 64) 6.67  (14.91) 19.79  (24.28)
Dyspnea: C25D1 (n= 3, 60) 11.11  (19.24) 20.00  (22.30)
Dyspnea: C26D1 (n= 3, 55) 0.00  (0.00) 20.00  (24.51)
Dyspnea: C27D1 (n= 3, 52) 0.00  (0.00) 16.03  (19.23)
Dyspnea: C28D1 (n= 1, 49) 0.00 [2]   (NA) 17.01  (20.55)
Dyspnea: C29D1 (n= 2, 40) 33.33  (47.14) 15.00  (21.28)
Dyspnea: C30D1 (n= 1, 31) 0.00 [2]   (NA) 16.13  (18.99)
Dyspnea: C31D1 (n= 0, 24) NA [3]   (NA) 22.22  (23.40)
Dyspnea: C32D1 (n= 0, 22) NA [3]   (NA) 22.73  (21.54)
Dyspnea: C33D1 (n= 0, 16) NA [3]   (NA) 25.00  (31.03)
Dyspnea: C34D1 (n= 0, 14) NA [3]   (NA) 26.19  (26.73)
Dyspnea: C35D1 (n= 0, 12) NA [3]   (NA) 25.00  (25.13)
Dyspnea: C36D1 (n= 0, 8) NA [3]   (NA) 20.83  (17.25)
Dyspnea: C37D1 (n= 0, 5) NA [3]   (NA) 26.67  (14.91)
Dyspnea: C38D1 (n= 0, 2) NA [3]   (NA) 33.33  (0.00)
Dyspnea: EOT(n= 266, 247) 38.72  (30.51) 39.41  (32.57)
Dyspnea: Pro Week 6 Pd (n= 0, 1) NA [3]   (NA) 33.33 [2]   (NA)
Dyspnea: Survival Follow-Up 1 (n= 2, 1) 33.33  (47.14) 33.33 [2]   (NA)
[1]
Data not reported because standard deviation (SD) was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[3]
Data not reported because no participant was evaluated for this category
22.Secondary Outcome
Title EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Hide Description EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Cognitive: Baseline (n= 390, 411) 83.38  (20.68) 85.16  (19.16)
Cognitive: C2D1 (n= 341, 363) 83.38  (21.64) 84.94  (19.30)
Cognitive: C3D1(n= 256, 305) 84.05  (19.82) 86.28  (17.32)
Cognitive: C4D1(n= 224, 281) 84.82  (19.27) 85.35  (19.87)
Cognitive: C5D1(n= 166, 238) 86.04  (17.24) 84.38  (19.73)
Cognitive: C6D1(n= 151, 224) 86.09  (18.20) 84.45  (20.27)
Cognitive: C7D1(n= 87, 189) 87.55  (16.32) 84.74  (18.93)
Cognitive: C8D1(n= 72, 171) 89.58  (13.83) 85.58  (18.87)
Cognitive: C9D1(n= 50, 153) 90.00  (14.29) 85.95  (18.65)
Cognitive: C10D1(n= 47, 146) 91.13  (11.96) 86.53  (19.31)
Cognitive: C11D1(n= 36, 134) 92.59  (10.87) 85.95  (19.91)
Cognitive: C12D1(n= 30, 132) 91.11  (12.17) 84.22  (20.52)
Cognitive: C13D1(n= 18, 124) 90.74  (11.75) 84.27  (21.50)
Cognitive: C14D1(n= 17, 121) 92.16  (11.96) 85.67  (18.30)
Cognitive: C15D1(n= 15, 113) 93.33  (10.54) 85.10  (19.08)
Cognitive: C16D1(n= 12, 109) 97.22  (6.49) 85.32  (21.12)
Cognitive: C17D1(n= 11, 98) 96.97  (6.74) 85.37  (20.48)
Cognitive: C18D1(n= 10, 92) 91.67  (11.79) 82.97  (20.52)
Cognitive: C19D1(n= 9, 84) 92.59  (12.11) 83.53  (20.12)
Cognitive: C20D1(n= 9, 80) 90.74  (14.70) 82.29  (22.87)
Cognitive: C21D1(n= 9, 75) 87.04  (23.24) 83.78  (20.32)
Cognitive: C22D1(n= 8, 68) 89.58  (12.40) 84.56  (21.03)
Cognitive: C23D1(n= 8, 66) 95.83  (7.72) 84.09  (20.55)
Cognitive: C24D1(n= 5, 64) 83.33  (23.57) 83.85  (23.56)
Cognitive: C25D1(n= 3, 60) 72.22  (25.46) 83.61  (21.59)
Cognitive: C26D1(n= 3, 55) 77.78  (19.24) 82.73  (21.51)
Cognitive: C27D1(n= 3, 52) 88.89  (19.24) 85.26  (20.25)
Cognitive: C28D1(n= 1, 48) 100.00 [1]   (NA) 85.07  (20.98)
Cognitive: C29D1(n= 2, 40) 50.00  (70.71) 83.75  (20.84)
Cognitive: C30D1(n= 1, 31) 100.00 [1]   (NA) 86.02  (20.68)
Cognitive: C31D1(n= 0, 24) NA [2]   (NA) 80.56  (21.23)
Cognitive: C32D1(n= 0, 22) NA [2]   (NA) 82.58  (22.11)
Cognitive: C33D1(n= 0,16) NA [2]   (NA) 77.08  (25.73)
Cognitive: C34D1(n= 0, 14) NA [2]   (NA) 80.95  (24.33)
Cognitive: C35D1(n= 0, 12) NA [2]   (NA) 76.39  (21.86)
Cognitive: C36D1(n= 0, 8) NA [2]   (NA) 83.33  (15.43)
Cognitive: C37D1(n= 0, 5) NA [2]   (NA) 83.33  (16.67)
Cognitive: C38D1(n= 0, 2) NA [2]   (NA) 91.67  (11.79)
Cognitive: EOT (n= 266, 246) 78.82  (24.54) 78.52  (22.50)
Cognitive: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 83.33 [1]   (NA)
Cognitive: Survival FU 1 (n= 2, 1) 50.00  (47.14) 0.00 [1]   (NA)
Emotional: Baseline (n= 390, 411) 75.83  (22.59) 76.55  (21.77)
Emotional: C2D1(n= 341, 363) 78.06  (22.63) 79.47  (20.72)
Emotional: C3D1(n= 256, 305) 79.70  (22.24) 82.71  (17.45)
Emotional: C4D1(n= 224, 280) 81.67  (20.36) 83.69  (17.70)
Emotional: C5D1(n= 166, 238) 80.52  (20.24) 81.99  (19.22)
Emotional: C6D1(n= 151, 224) 81.73  (20.50) 82.70  (19.91)
Emotional: C7D1(n= 87, 189) 81.42  (22.00) 83.77  (17.71)
Emotional: C8D1(n= 72, 171) 84.38  (18.66) 83.63  (19.40)
Emotional: C9D1(n= 50, 153) 86.00  (17.93) 85.62  (18.72)
Emotional: C10D1(n= 47, 146) 84.93  (17.69) 84.13  (19.74)
Emotional: C11D1(n= 36, 134) 89.12  (15.15) 84.16  (18.14)
Emotional: C12D1(n= 30, 132) 86.94  (14.79) 84.34  (20.10)
Emotional: C13D1(n= 18, 123) 89.35  (14.52) 84.35  (19.75)
Emotional: C14D1(n= 17, 121) 86.27  (15.57) 84.25  (19.11)
Emotional: C15D1(n= 15, 113) 90.00  (14.16) 83.87  (20.04)
Emotional: C16D1(n= 12, 109) 88.89  (16.02) 82.11  (22.59)
Emotional: C17D1(n= 11, 98) 88.64  (17.59) 83.25  (19.50)
Emotional: C18D1(n= 10, 92) 87.50  (19.35) 82.52  (21.11)
Emotional: C19D1(n= 9, 84) 87.96  (19.14) 81.42  (20.55)
Emotional: C20D1(n=9, 80) 76.85  (34.30) 83.19  (18.90)
Emotional: C21D1(n= 9, 75) 83.33  (26.68) 84.19  (17.58)
Emotional: C22D1(n= 8, 68) 76.74  (32.60) 86.03  (16.44)
Emotional: C23D1(n= 8, 66) 89.58  (15.91) 87.00  (17.55)
Emotional: C24D1(n=5, 65) 78.33  (33.12) 83.72  (19.18)
Emotional: C25D1(n= 3, 60) 100.00  (0.00) 83.66  (18.77)
Emotional: C26D1(n= 3, 55) 86.11  (12.73) 85.15  (19.69)
Emotional: C27D1(n= 3, 52) 100.00  (0.00) 86.38  (18.38)
Emotional: C28D1(n= 1, 48) 100.00 [1]   (NA) 86.92  (17.51)
Emotional: C29D1(n= 2, 40) 50.00  (70.71) 87.50  (16.45)
Emotional: C30D1(n= 1, 31) 100.00 [1]   (NA) 89.79  (15.62)
Emotional: C31D1(n= 0, 24) NA [2]   (NA) 85.76  (18.30)
Emotional: C32D1(n= 0, 22) NA [2]   (NA) 82.95  (20.81)
Emotional: C33D1(n= 0, 16) NA [2]   (NA) 81.25  (25.37)
Emotional: C34D1(n= 0, 14) NA [2]   (NA) 82.14  (25.29)
Emotional: C35D1(n= 0, 12) NA [2]   (NA) 83.33  (21.61)
Emotional: C36D1(n= 0, 8) NA [2]   (NA) 95.83  (11.78)
Emotional: C37D1(n= 0, 5) NA [2]   (NA) 90.00  (14.91)
Emotional: C38D1(n= 0, 2) NA [2]   (NA) 83.33  (23.57)
Emotional: EOT (n= 265, 246) 73.78  (26.29) 73.92  (23.74)
Emotional: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 66.67 [1]   (NA)
Emotional: Survival FU-1 (n= 2,1) 25.00  (35.36) 33.33 [1]   (NA)
Physical: Baseline (n= 390, 413) 73.27  (22.58) 74.46  (20.66)
Physical: C2D1(n= 343, 369) 72.64  (22.00) 71.70  (22.49)
Physical: C3D1(n= 255, 304) 74.98  (21.60) 76.19  (19.48)
Physical: C4D1(n= 224, 277) 75.72  (19.05) 76.79  (19.95)
Physical: C5D1(n= 167, 238) 77.30  (19.00) 77.79  (19.89)
Physical: C6D1(n= 151, 225) 74.77  (19.26) 78.93  (18.76)
Physical: C7D1(n= 88, 189) 77.61  (18.08) 79.20  (18.42)
Physical: C8D1(n= 71, 170) 78.45  (17.72) 78.87  (18.91)
Physical: C9D1(n= 50, 153) 79.07  (20.43) 79.46  (18.75)
Physical: C10D1(n= 47, 146) 79.29  (19.96) 79.41  (18.85)
Physical: C11D1(n= 37, 134) 81.44  (20.85) 79.09  (20.50)
Physical: C12D1(n= 30, 132) 82.22  (15.69) 79.72  (18.84)
Physical: C13D1(n= 19, 124) 87.37  (9.66) 80.48  (19.33)
Physical: C14D1(n= 18, 121) 85.56  (9.50) 80.33  (17.55)
Physical: C15D1(n= 16, 113) 86.25  (8.24) 79.88  (18.64)
Physical: C16D1(n= 13, 109) 85.13  (9.49) 78.82  (21.32)
Physical: C17D1(n= 11, 98) 84.24  (12.03) 78.57  (20.89)
Physical: C18D1(n= 10, 92) 82.67  (13.03) 79.64  (19.92)
Physical: C19D1(n= 9, 84) 87.41  (10.77) 78.97  (20.48)
Physical: C20D1(n= 9, 80) 81.48  (18.19) 79.19  (20.26)
Physical: C21D1(n= 9, 75) 87.41  (11.28) 78.67  (20.68)
Physical: C22D1(n= 8, 69) 82.50  (19.82) 82.51  (16.92)
Physical: C23D1(n= 8, 66) 85.00  (13.21) 80.81  (17.56)
Physical: C24D1(n= 5, 64) 80.00  (18.26) 81.41  (17.69)
Physical: C25D1(n= 3, 60) 82.22  (16.78) 83.22  (16.67)
Physical: C26D1(n= 3, 55) 75.56  (3.85) 80.12  (17.43)
Physical: C27D1(n= 2, 52) 76.67  (4.71) 81.89  (16.90)
Physical: C28D1(n= 2, 49) 65.00  (21.21) 84.15  (14.41)
Physical: C29D1(n= 2, 40) 56.67  (33.00) 83.00  (14.87)
Physical: C30D1(n= 1, 31) 80.00 [1]   (NA) 83.01  (15.67)
Physical: C31D1(n= 0, 24) NA [2]   (NA) 78.61  (17.25)
Physical: C32D1(n= 0, 22) NA [2]   (NA) 75.15  (18.42)
Physical: C33D1(n= 0, 16) NA [2]   (NA) 77.92  (17.84)
Physical: C34D1(n= 0, 14) NA [2]   (NA) 75.24  (19.47)
Physical: C35D1(n= 0, 12) NA [2]   (NA) 73.89  (20.78)
Physical: C36D1(n= 0, 8) NA [2]   (NA) 83.33  (17.46)
Physical: C37D1(n= 0, 5) NA [2]   (NA) 74.67  (14.45)
Physical: C38D1(n= 0, 2) NA [2]   (NA) 86.67  (0.00)
Physical: EOT(n= 267, 246) 63.59  (24.57) 64.78  (26.47)
Physical: Pro Week 6 Pd(n= 0, 1) NA [2]   (NA) 46.67 [1]   (NA)
Physical: Survival FU-1 (n= 2, 1) 36.67  (51.85) 46.67 [1]   (NA)
Role: Baseline (n=388, 413) 70.92  (30.68) 73.61  (29.13)
Role: C2D1 (n=339, 369) 69.91  (29.89) 68.29  (31.50)
Role: C3D1 (n=256, 304) 74.61  (27.21) 75.27  (27.28)
Role: C4D1 (n=224, 279) 73.36  (26.22) 76.70  (25.27)
Role: C5D1 (n=167, 238) 74.35  (25.00) 76.05  (26.97)
Role: C6D1 (n=151, 225) 73.62  (26.62) 77.70  (26.78)
Role: C7D1 (n=88, 190) 77.27  (23.19) 79.04  (24.97)
Role: C8D1 (n=72, 170) 73.61  (26.50) 77.35  (25.22)
Role: C9D1 (n=50, 153) 77.67  (24.42) 79.30  (25.36)
Role: C10D1 (n=47, 145) 78.72  (27.74) 81.38  (24.34)
Role: C11D1 (n=37, 134) 80.63  (24.69) 78.61  (27.01)
Role: C12D1 (n=30, 132) 81.11  (22.20) 79.80  (25.97)
Role: C13D1 (n=19, 124) 84.21  (18.82) 79.44  (26.55)
Role: C14D1 (n=18, 121) 78.70  (21.24) 79.48  (24.98)
Role: C15D1 (n=16, 113) 83.33  (14.91) 79.20  (25.05)
Role: C16D1 (n=13, 109) 85.90  (19.06) 76.45  (27.89)
Role: C17D1 (n=11, 98) 80.30  (20.84) 76.02  (29.22)
Role: C18D1 (n=10, 92) 80.00  (26.99) 77.17  (27.59)
Role: C19D1 (n=9, 84) 85.19  (22.74) 78.17  (28.46)
Role: C20D1 (n=9, 80) 79.63  (29.79) 78.54  (26.01)
Role: C21D1 (n=9, 75) 85.19  (15.47) 77.33  (28.29)
Role: C22D1 (n=8, 69) 79.17  (35.36) 81.64  (26.68)
Role: C23D1 (n=8, 66) 85.42  (20.77) 80.30  (26.13)
Role: C24D1 (n=5, 65) 70.00  (34.16) 78.72  (26.92)
Role: C25D1 (n=3, 60) 77.78  (38.49) 79.44  (27.34)
Role: C26D1 (n=3, 55) 83.33  (28.87) 76.97  (27.31)
Role: C27D1 (n=3, 52) 88.89  (19.24) 80.77  (26.89)
Role: C28D1 (n=1, 49) 100.00 [1]   (NA) 82.99  (22.69)
Role: C29D1 (n=2, 40) 66.67  (47.14) 83.33  (24.75)
Role: C30D1 (n=1, 31) 100.00 [1]   (NA) 81.72  (24.10)
Role: C31D1(n=0, 24) NA [2]   (NA) 79.86  (25.53)
Role: C32D1(n=0, 22) NA [2]   (NA) 75.00  (27.58)
Role: C33D1(n=0, 16) NA [2]   (NA) 66.67  (34.43)
Role: C34D1(n=0, 14) NA [2]   (NA) 69.05  (33.88)
Role: C35D1(n=0, 12) NA [2]   (NA) 69.44  (32.44)
Role: C36D1(n=0, 8) NA [2]   (NA) 87.50  (17.25)
Role: C37D1(n=0, 5) NA [2]   (NA) 76.67  (22.36)
Role: C38D1(n=0, 2) NA [2]   (NA) 100.00  (0.00)
Role: EOT(n=266, 246) 58.52  (32.99) 60.03  (33.25)
Role: Pro Week 6 Pd (n=0, 1) NA [2]   (NA) 66.67 [1]   (NA)
Role: Survival FU-1 (n=2,1) 33.33  (47.14) 33.33 [1]   (NA)
Social: Baseline (n= 389, 411) 74.16  (26.92) 77.41  (26.13)
Social: C2D1(n= 340, 363) 74.51  (26.50) 76.86  (26.25)
Social: C3D1(n= 255, 305) 78.37  (25.30) 81.15  (23.70)
Social: C4D1(n= 223, 280) 79.60  (23.00) 81.31  (24.15)
Social: C5D1(n= 166, 238) 79.32  (22.26) 82.00  (24.39)
Social: C6D1(n= 151, 224) 78.15  (24.05) 81.99  (23.80)
Social: C7D1(n= 87, 189) 80.65  (22.57) 82.80  (22.54)
Social: C8D1(n= 72, 171) 81.94  (22.16) 81.19  (23.95)
Social: C9D1(n= 50, 153) 82.00  (22.80) 83.77  (22.29)
Social: C10D1(n= 47, 146) 81.21  (24.97) 83.79  (22.99)
Social: C11D1(n= 36, 134) 82.41  (26.11) 81.47  (25.42)
Social: C12D1(n= 30, 132) 86.67  (18.77) 82.95  (24.58)
Social: C13D1(n= 18, 124) 89.81  (15.27) 84.27  (22.82)
Social: C14D1(n= 17, 121) 86.27  (19.75) 84.16  (22.55)
Social: C15D1(n= 15, 113) 93.33  (13.80) 83.92  (22.26)
Social: C16D1(n= 12, 109) 84.72  (16.60) 82.72  (24.73)
Social: C17D1(n= 11, 98) 87.88  (16.82) 82.99  (23.57)
Social: C18D1(n= 10, 92) 86.67  (17.21) 81.34  (24.06)
Social: C19D1(n= 9, 84) 88.89  (16.67) 81.94  (25.90)
Social: C20D1(n= 9, 80) 81.48  (33.79) 81.46  (24.73)
Social: C21D1(n= 9, 75) 85.19  (24.22) 78.67  (27.88)
Social: C22D1(n= 8, 68) 85.42  (30.13) 84.31  (25.41)
Social: C23D1(n= 8, 66) 91.67  (15.43) 80.56  (26.24)
Social: C24D1(n= 5, 65) 80.00  (27.39) 80.77  (25.38)
Social: C25D1(n= 3, 60) 77.78  (38.49) 81.39  (27.80)
Social: C26D1(n= 3, 55) 77.78  (19.24) 79.70  (27.53)
Social: C27D1(n= 3, 52) 88.89  (19.24) 82.05  (25.32)
Social: C28D1(n= 1, 48) 100.00 [1]   (NA) 84.03  (24.30)
Social: C29D1(n= 2, 40) 50.00  (70.71) 82.92  (24.60)
Social: C30D1(n= 1, 31) 100.00 [1]   (NA) 79.57  (27.79)
Social: C31D1(n= 0, 24) NA [2]   (NA) 79.17  (26.12)
Social: C32D1(n= 0, 22) NA [2]   (NA) 73.48  (30.71)
Social: C33D1(n= 0, 16) NA [2]   (NA) 73.96  (32.19)
Social: C34D1(n= 0, 14) NA [2]   (NA) 67.86  (34.88)
Social: C35D1(n= 0, 12) NA [2]   (NA) 70.83  (31.88)
Social: C36D1(n= 0, 8) NA [2]   (NA) 87.50  (17.25)
Social: C37D1(n= 0, 5) NA [2]   (NA) 80.00  (18.26)
Social: C38D1(n= 0, 2) NA [2]   (NA) 100.00  (0.00)
Social: EOT(n= 264, 245) 69.51  (30.65) 70.00  (30.05)
Social: Pro Week 6 Pd(n= 0, 1) NA [2]   (NA) 66.67 [1]   (NA)
Social: Survival FU-1 (n= 2, 1) 83.33  (23.57) 16.67 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
23.Secondary Outcome
Title EORTC QLQ-C30 Questionnaire Score: GHS Scale
Hide Description EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Global Health: Baseline (n= 387, 410) 60.55  (22.25) 61.24  (22.31)
Global Health: C2D1(n= 339, 361) 59.56  (22.15) 58.93  (23.57)
Global Health: C3D1(n= 255, 304) 64.64  (18.66) 64.61  (20.74)
Global Health: C4D1(n= 222, 279) 63.51  (20.67) 65.11  (21.36)
Global Health: C5D1(n= 166, 235) 64.01  (18.37) 66.35  (19.84)
Global Health: C6D1(n= 151, 223) 64.51  (19.59) 65.73  (21.42)
Global Health: C7D1(n= 87, 187) 64.85  (18.13) 66.93  (19.61)
Global Health: C8D1(n= 72, 169) 62.73  (20.22) 67.36  (19.45)
Global Health: C9D1(n= 50, 152) 67.17  (18.93) 68.09  (19.46)
Global Health: C10D1(n= 47, 145) 66.84  (18.67) 69.37  (20.90)
Global Health: C11D1(n= 36, 133) 69.68  (17.15) 68.17  (21.24)
Global Health: C12D1(n= 30, 131) 66.67  (18.05) 68.32  (20.42)
Global Health: C13D1(n= 18, 124) 69.91  (14.33) 67.74  (22.52)
Global Health: C14D1(n= 17, 120) 69.61  (14.71) 67.01  (20.62)
Global Health: C15D1(n= 15, 113) 69.44  (17.16) 68.66  (20.21)
Global Health: C16D1(n= 12, 109) 62.50  (15.69) 67.97  (21.67)
Global Health: C17D1(n= 10, 98) 61.67  (19.72) 68.62  (19.84)
Global Health: C18D1(n= 10, 92) 61.67  (21.23) 68.57  (18.86)
Global Health: C19D1(n= 9, 84) 65.74  (21.43) 68.25  (20.10)
Global Health: C20D1(n= 9, 80) 62.04  (26.72) 68.12  (20.10)
Global Health: C21D1(n= 9, 75) 60.19  (29.98) 66.56  (21.55)
Global Health: C22D1(n= 8, 68) 54.17  (24.80) 73.28  (17.13)
Global Health: C23D1(n= 8, 66) 62.50  (19.42) 70.45  (18.09)
Global Health: C24D1(n= 5, 65) 70.00  (27.39) 69.36  (19.27)
Global Health: C25D1(n= 3, 60) 66.67  (28.87) 69.03  (19.23)
Global Health: C26D1(n= 3, 55) 66.67  (28.87) 68.64  (20.60)
Global Health: C27D1(n= 3, 52) 66.67  (28.87) 68.91  (21.84)
Global Health: C28D1(n= 2, 48) 87.50  (17.68) 71.87  (20.60)
Global Health: C29D1(n= 2, 40) 91.67  (11.79) 72.71  (20.06)
Global Health: C30D1(n= 1, 30) 83.33 [1]   (NA) 75.28  (18.63)
Global Health: C31D1(n= 0, 24) NA [2]   (NA) 71.53  (21.13)
Global Health: C32D1(n= 0, 22) NA [2]   (NA) 70.45  (20.21)
Global Health: C33D1(n= 0,16) NA [2]   (NA) 67.19  (27.30)
Global Health: C34D1(n= 0, 14) NA [2]   (NA) 68.45  (26.19)
Global Health: C35D1(n= 0, 12) NA [2]   (NA) 69.44  (26.43)
Global Health: C36D1(n= 0, 8) NA [2]   (NA) 80.21  (16.63)
Global Health: C37D1(n= 0, 5) NA [2]   (NA) 76.67  (19.00)
Global Health: C38D1(n= 0, 2) NA [2]   (NA) 91.67  (11.79)
Global Health: EOT(n= 262, 245) 51.69  (24.02) 52.82  (24.48)
Global Health: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 50.00 [1]   (NA)
Global Health: Survival FU 1 (n= 2, 1) 58.33  (35.36) 33.33 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
24.Secondary Outcome
Title EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Hide Description EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Nausea/Vomiting: Baseline (n= 389, 413) 8.01  (16.34) 7.59  (16.35)
Nausea/Vomiting: C2D1(n= 342, 369) 11.50  (19.30) 9.53  (17.25)
Nausea/Vomiting: C3D1(n= 253, 305) 7.05  (15.06) 7.27  (15.32)
Nausea/Vomiting: C4D1(n= 223, 279) 7.40  (14.37) 7.17  (15.50)
Nausea/Vomiting: C5D1(n= 167, 238) 6.29  (12.49) 6.44  (14.54)
Nausea/Vomiting: C6D1(n= 151, 225) 6.40  (13.17) 6.44  (15.16)
Nausea/Vomiting: C7D1(n= 88, 190) 6.82  (13.28) 5.61  (13.74)
Nausea/Vomiting: C8D1(n= 72, 170) 6.02  (12.91) 4.61  (10.57)
Nausea/Vomiting: C9D1(n= 50, 153) 3.33  (8.91) 2.83  (8.06)
Nausea/Vomiting: C10D1(n= 47, 146) 2.48  (6.93) 3.54  (10.02)
Nausea/Vomiting: C11D1(n= 37, 134) 3.15  (6.62) 3.23  (8.54)
Nausea/Vomiting: C12D1(n= 30, 132) 3.89  (8.40) 3.03  (7.66)
Nausea/Vomiting: C13D1(n= 19, 124) 4.39  (9.37) 3.36  (10.19)
Nausea/Vomiting: C14D1(n= 18, 121) 4.63  (9.58) 3.31  (9.03)
Nausea/Vomiting: C15D1(n= 16, 113) 1.04  (4.17) 3.83  (11.14)
Nausea/Vomiting: C16D1(n= 13, 109) 5.13  (10.51) 2.75  (8.64)
Nausea/Vomiting: C17D1(n= 11, 98) 9.09  (13.67) 2.55  (8.06)
Nausea/Vomiting: C18D1(n= 10, 92) 6.67  (11.65) 3.08  (8.88)
Nausea/Vomiting: C19D1(n= 9, 84) 3.70  (7.35) 4.17  (11.53)
Nausea/Vomiting: C20D1(n= 9, 80) 5.56  (8.33) 3.13  (11.28)
Nausea/Vomiting: C21D1(n= 9, 75) 1.85  (5.56) 4.89  (13.08)
Nausea/Vomiting: C22D1(n= 8, 69) 6.25  (8.63) 1.93  (7.31)
Nausea/Vomiting: C23D1(n= 8, 66) 6.25  (12.40) 2.53  (6.69)
Nausea/Vomiting: C24D1(n= 5, 64) 0.00  (0.00) 2.34  (7.19)
Nausea/Vomiting: C25D1(n= 3, 60) 0.00  (0.00) 1.94  (6.21)
Nausea/Vomiting: C26D1(n= 3, 55) 0.00  (0.00) 2.73  (8.34)
Nausea/Vomiting: C27D1(n= 3, 52) 0.00  (0.00) 2.24  (6.62)
Nausea/Vomiting: C28D1(n= 1, 49) 0.00 [1]   (NA) 1.02  (4.04)
Nausea/Vomiting: C29D1(n= 2, 40) 33.33  (47.14) 1.67  (5.06)
Nausea/Vomiting: C30D1(n= 1, 31) 0.00 [1]   (NA) 1.61  (5.01)
Nausea/Vomiting: C31D1(n= 0, 24) NA [2]   (NA) 2.08  (5.63)
Nausea/Vomiting: C32D1(n= 0, 22) NA [2]   (NA) 1.52  (4.90)
Nausea/Vomiting: C33D1(n= 0,16) NA [2]   (NA) 1.04  (4.17)
Nausea/Vomiting: C34D1(n= 0, 14) NA [2]   (NA) 2.38  (8.91)
Nausea/Vomiting: C35D1(n= 0, 12) NA [2]   (NA) 1.39  (4.81)
Nausea/Vomiting: C36D1(n= 0, 8) NA [2]   (NA) 4.17  (11.78)
Nausea/Vomiting: C37D1(n= 0, 5) NA [2]   (NA) 6.67  (9.13)
Nausea/Vomiting: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Nausea/Vomiting: EOT(n= 266, 245) 11.65  (20.11) 10.61  (17.62)
Nausea/Vomiting: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 16.67 [1]   (NA)
Nausea/Vomiting: Survival FU 1 (n= 2, 1) 50.00  (70.71) 66.67 [1]   (NA)
Pain: Baseline (n= 390, 413) 29.70  (29.45) 29.98  (29.72)
Pain: C2D1(n= 343, 368) 28.43  (27.24) 29.30  (29.03)
Pain: C3D1(n= 256, 305) 22.59  (24.93) 24.15  (27.50)
Pain: C4D1(n= 224, 280) 21.65  (24.48) 23.75  (25.84)
Pain: C5D1(n= 167, 239) 20.96  (22.55) 23.22  (25.41)
Pain: C6D1(n= 151, 225) 22.41  (21.95) 21.63  (24.68)
Pain: C7D1(n= 88, 190) 21.59  (22.34) 21.58  (25.30)
Pain: C8D1(n= 72, 171) 23.38  (22.49) 22.03  (24.36)
Pain: C9D1(n= 50, 153) 16.33  (20.89) 19.28  (23.50)
Pain: C10D1(n= 47, 146) 14.54  (17.93) 21.00  (24.61)
Pain: C11D1(n= 37, 134) 13.96  (22.05) 21.27  (26.60)
Pain: C12D1(n= 30, 132) 13.33  (21.17) 18.69  (24.71)
Pain: C13D1(n= 19, 124) 16.67  (25.46) 17.74  (21.23)
Pain: C14D1(n= 18, 120) 12.04  (15.97) 17.64  (22.17)
Pain: C15D1(n= 16, 113) 10.42  (17.08) 17.40  (22.86)
Pain: C16D1(n= 13, 109) 21.79  (21.93) 20.64  (25.25)
Pain: C17D1(n= 11, 98) 16.67  (19.72) 20.41  (25.39)
Pain: C18D1(n= 10, 92) 11.67  (22.29) 20.83  (24.54)
Pain: C19D1(n= 9, 84) 14.81  (22.74) 22.42  (28.16)
Pain: C20D1(n=9, 80) 27.78  (31.18) 20.00  (23.78)
Pain: C21D1(n= 9, 75) 14.81  (17.57) 19.78  (25.95)
Pain: C22D1(n= 8, 69) 18.75  (20.77) 15.22  (19.75)
Pain: C23D1(n= 8, 66) 14.58  (27.37) 16.92  (23.11)
Pain: C24D1(n=5, 64) 30.00  (36.13) 20.05  (25.05)
Pain: C25D1(n= 3, 60) 16.67  (28.87) 18.33  (22.90)
Pain: C26D1(n= 3, 55) 22.22  (19.24) 16.36  (21.87)
Pain: C27D1(n= 3, 52) 11.11  (19.24) 15.06  (20.41)
Pain: C28D1(n= 1, 49) 0.00 [1]   (NA) 14.29  (18.63)
Pain: C29D1(n= 2, 40) 41.67  (58.93) 13.75  (18.06)
Pain: C30D1(n= 1, 31) 0.00 [1]   (NA) 15.05  (21.24)
Pain: C31D1(n= 0, 24) NA [2]   (NA) 14.58  (21.03)
Pain: C32D1(n= 0, 22) NA [2]   (NA) 16.67  (24.67)
Pain: C33D1(n= 0, 16) NA [2]   (NA) 20.83  (27.55)
Pain: C34D1(n= 0, 14) NA [2]   (NA) 26.19  (27.51)
Pain: C35D1(n= 0, 12) NA [2]   (NA) 22.22  (25.95)
Pain: C36D1(n= 0, 8) NA [2]   (NA) 22.92  (34.43)
Pain: C37D1(n= 0, 5) NA [2]   (NA) 30.00  (34.16)
Pain: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Pain: EOT (n= 267, 247) 32.21  (30.36) 35.43  (31.22)
Pain: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 16.67 [1]   (NA)
Pain: Survival FU-1 (n= 2,1) 66.67  (47.14) 83.33 [1]   (NA)
Fatigue: Baseline (n= 390, 413) 37.59  (25.69) 36.21  (23.92)
Fatigue: C2D1(n= 343, 369) 40.52  (25.68) 39.78  (26.17)
Fatigue: C3D1(n= 256, 304) 35.29  (23.97) 33.90  (23.75)
Fatigue: C4D1(n= 224, 278) 35.59  (23.10) 30.72  (22.57)
Fatigue: C5D1(n= 167, 238) 36.03  (22.40) 30.95  (24.13)
Fatigue: C6D1(n= 151, 225) 36.28  (23.40) 28.89  (22.66)
Fatigue: C7D1(n= 88, 190) 34.34  (23.02) 28.33  (22.15)
Fatigue: C8D1(n= 72, 170) 30.86  (24.12) 27.97  (21.56)
Fatigue: C9D1(n= 50, 153) 28.67  (23.45) 25.78  (21.39)
Fatigue: C10D1(n= 47, 145) 29.31  (25.21) 26.32  (22.27)
Fatigue: C11D1(n= 37, 134) 27.63  (25.07) 25.62  (23.05)
Fatigue: C12D1(n= 30, 132) 28.89  (23.99) 26.60  (23.37)
Fatigue: C13D1(n= 19, 124) 22.22  (20.29) 27.51  (22.73)
Fatigue: C14D1(n= 18, 121) 21.60  (16.82) 26.31  (23.13)
Fatigue: C15D1(n= 16, 112) 20.14  (18.24) 27.73  (22.56)
Fatigue: C16D1(n= 13, 109) 21.79  (17.64) 27.22  (23.35)
Fatigue: C17D1(n= 11, 98) 22.22  (12.17) 27.21  (23.56)
Fatigue: C18D1(n= 10, 92) 26.67  (17.53) 27.29  (24.18)
Fatigue: C19D1(n= 9, 84) 22.22  (14.70) 27.65  (22.85)
Fatigue: C20D1(n= 9, 80) 32.10  (30.15) 25.21  (23.47)
Fatigue: C21D1(n= 9, 75) 28.39  (18.52) 26.44  (23.66)
Fatigue: C22D1(n= 8, 69) 33.33  (29.10) 22.38  (21.77)
Fatigue: C23D1(n= 8, 66) 25.00  (24.31) 24.16  (20.59)
Fatigue: C24D1(n= 5, 64) 31.11  (40.37) 23.78  (18.87)
Fatigue: C25D1(n= 3, 60) 11.11  (19.24) 23.89  (20.94)
Fatigue: C26D1(n= 3, 55) 18.52  (16.97) 28.69  (24.54)
Fatigue: C27D1(n= 3, 52) 11.11  (19.24) 22.65  (19.80)
Fatigue: C28D1(n= 1, 49) 0.00 [1]   (NA) 22.34  (18.23)
Fatigue: C29D1(n= 2, 40) 44.44  (47.14) 21.11  (18.63)
Fatigue: C30D1(n= 1, 31) 22.22 [1]   (NA) 23.66  (20.23)
Fatigue: C31D1(n= 0, 24) NA [2]   (NA) 23.15  (20.96)
Fatigue: C32D1(n= 0, 22) NA [2]   (NA) 25.25  (20.63)
Fatigue: C33D1(n= 0, 16) NA [2]   (NA) 29.86  (26.52)
Fatigue: C34D1(n= 0, 14) NA [2]   (NA) 31.75  (24.21)
Fatigue: C35D1(n= 0, 12) NA [2]   (NA) 25.00  (21.25)
Fatigue: C36D1(n= 0, 8) NA [2]   (NA) 16.67  (15.71)
Fatigue: C37D1(n= 0, 5) NA [2]   (NA) 24.44  (16.48)
Fatigue: C38D1(n= 0, 2) NA [2]   (NA) 16.67  (7.86)
Fatigue: EOT(n= 267, 246) 47.50  (26.72) 43.07  (28.15)
Fatigue: Pro Week 6 Pd(n= 0, 1) NA [2]   (NA) 44.44 [1]   (NA)
Fatigue: Survival FU-1 (n= 2, 1) 83.33  (23.57) 88.89 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
25.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Alopecia
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Alopecia: Baseline (n= 384, 405) 13.89  (27.95) 14.32  (29.07)
Alopecia: C2D1(n= 332, 357) 60.44  (36.66) 6.63  (16.84)
Alopecia: C3D1(n= 248, 300) 56.72  (35.86) 7.44  (18.89)
Alopecia: C4D1(n= 219, 270) 52.36  (35.24) 7.41  (19.14)
Alopecia: C5D1(n= 163, 234) 56.65  (37.25) 6.41  (16.68)
Alopecia: C6D1(n= 147, 220) 54.42  (37.64) 7.88  (19.34)
Alopecia: C7D1(n= 87, 186) 52.11  (39.28) 5.91  (16.10)
Alopecia: C8D1(n= 70, 166) 48.57  (37.94) 6.63  (17.68)
Alopecia: C9D1(n= 47, 150) 48.23  (39.81) 5.11  (14.83)
Alopecia: C10D1(n= 45, 142) 49.63  (39.96) 3.76  (13.23)
Alopecia: C11D1(n= 36, 130) 47.22  (45.34) 3.08  (11.33)
Alopecia: C12D1(n= 29, 129) 36.78  (43.04) 4.91  (13.88)
Alopecia: C13D1(n= 19, 121) 42.11  (41.34) 6.06  (15.52)
Alopecia: C14D1(n= 18, 119) 29.63  (35.95) 5.60  (14.60)
Alopecia: C15D1(n= 16, 110) 33.33  (34.43) 7.27  (17.12)
Alopecia: C16D1(n= 12, 105) 27.78  (31.25) 7.30  (17.89)
Alopecia: C17D1(n= 11, 95) 21.21  (30.81) 9.47  (19.85)
Alopecia: C18D1(n= 9, 90) 22.22  (33.33) 8.89  (17.16)
Alopecia: C19D1(n= 8, 81) 25.00  (34.50) 10.29  (18.74)
Alopecia: C20D1(n= 9, 78) 44.44  (44.10) 8.55  (15.60)
Alopecia: C21D1(n= 9, 73) 22.22  (33.33) 9.59  (16.18)
Alopecia: C22D1(n= 7, 67) 9.52  (16.26) 9.45  (16.21)
Alopecia: C23D1(n= 8, 64) 29.17  (37.53) 11.46  (18.99)
Alopecia: C24D1(n= 5, 62) 13.33  (18.26) 8.06  (15.61)
Alopecia: C25D1(n= 2, 58) 0.00  (0.00) 9.77  (16.53)
Alopecia: C26D1(n= 2, 53) 0.00  (0.00) 9.43  (16.51)
Alopecia: C27D1(n= 3, 50) 33.33  (57.74) 9.33  (16.55)
Alopecia: C28D1(n= 2, 46) 0.00  (0.00) 6.52  (15.10)
Alopecia: C29D1(n= 2, 38) 0.00  (0.00) 8.77  (20.04)
Alopecia: C30D1(n= 1, 31) 0.00 [1]   (NA) 10.75  (19.98)
Alopecia: C31D1(n= 0, 24) NA [2]   (NA) 9.72  (20.80)
Alopecia: C32D1(n= 0, 23) NA [2]   (NA) 7.25  (19.99)
Alopecia: C33D1(n= 0,16) NA [2]   (NA) 8.33  (22.77)
Alopecia: C34D1(n= 0, 14) NA [2]   (NA) 9.52  (20.38)
Alopecia: C35D1(n= 0, 11) NA [2]   (NA) 6.06  (13.48)
Alopecia: C36D1(n= 0, 8) NA [2]   (NA) 4.17  (11.78)
Alopecia: C37D1(n= 0, 5) NA [2]   (NA) 6.67  (14.91)
Alopecia: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Alopecia: EOT(n= 261, 243) 53.51  (38.91) 6.58  (17.48)
Alopecia: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 100.00 [1]   (NA)
Alopecia: Survival FU 1 (n= 2, 1) 100.00  (0.00) 66.67 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
26.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Coughing
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Coughing: Baseline (n= 383, 406) 38.73  (29.64) 37.27  (27.23)
Coughing: C2D1(n= 333, 360) 36.54  (28.04) 37.50  (28.33)
Coughing: C3D1(n= 250, 298) 33.73  (27.46) 33.89  (24.99)
Coughing: C4D1(n= 219, 272) 31.35  (24.13) 32.48  (25.52)
Coughing: C5D1(n= 164, 235) 32.72  (23.49) 31.35  (25.52)
Coughing: C6D1(n= 147, 219) 31.75  (24.78) 31.05  (24.73)
Coughing: C7D1(n= 87, 185) 32.95  (24.64) 30.99  (25.07)
Coughing: C8D1(n= 69, 166) 30.43  (28.43) 29.12  (25.73)
Coughing: C9D1(n= 50, 150) 24.67  (17.57) 29.11  (24.52)
Coughing: C10D1(n= 47, 140) 23.40  (19.55) 27.86  (22.83)
Coughing: C11D1(n= 37, 129) 21.62  (19.59) 27.39  (23.37)
Coughing: C12D1(n= 30, 129) 20.00  (18.77) 25.06  (23.95)
Coughing: C13D1(n= 19, 121) 15.79  (17.10) 24.79  (23.78)
Coughing: C14D1(n= 18, 119) 16.67  (17.15) 24.37  (22.42)
Coughing: C15D1(n= 16, 110) 12.50  (16.67) 25.76  (23.31)
Coughing: C16D1(n= 13, 106) 20.51  (21.68) 24.53  (22.21)
Coughing: C17D1(n= 11, 94) 21.21  (16.82) 24.82  (23.92)
Coughing: C18D1(n= 10, 90) 26.67  (21.08) 26.30  (24.22)
Coughing: C19D1(n= 9, 82) 22.22  (16.67) 25.61  (26.86)
Coughing: C20D1(n= 9, 78) 25.93  (14.70) 28.21  (26.36)
Coughing: C21D1(n= 9, 73) 22.22  (16.67) 28.77  (27.95)
Coughing: C22D1(n= 8, 67) 25.00  (38.83) 22.89  (23.36)
Coughing: C23D1(n= 8, 64) 20.83  (17.25) 23.44  (26.35)
Coughing: C24D1(n= 5, 62) 26.67  (14.91) 24.73  (23.33)
Coughing: C25D1(n= 3, 58) 33.33  (0.00) 25.86  (23.40)
Coughing: C26D1(n= 3, 53) 44.44  (19.25) 26.41  (24.77)
Coughing: C27D1(n= 3, 50) 11.11  (19.24) 24.67  (22.14)
Coughing: C28D1(n= 2, 46) 16.67  (23.57) 20.29  (20.46)
Coughing: C29D1(n= 2, 38) 16.67  (23.57) 19.30  (22.77)
Coughing: C30D1(n= 1, 31) 0.00 [1]   (NA) 18.28  (20.80)
Coughing: C31D1(n= 0, 24) NA [2]   (NA) 23.61  (25.02)
Coughing: C32D1(n= 0, 23) NA [2]   (NA) 26.09  (19.99)
Coughing: C33D1(n= 0,16) NA [2]   (NA) 27.08  (32.70)
Coughing: C34D1(n= 0, 14) NA [2]   (NA) 26.19  (29.75)
Coughing: C35D1(n= 0, 11) NA [2]   (NA) 21.21  (22.47)
Coughing: C36D1(n= 0, 8) NA [2]   (NA) 25.00  (15.43)
Coughing: C37D1(n= 0, 5) NA [2]   (NA) 26.67  (14.91)
Coughing: C38D1(n= 0, 2) NA [2]   (NA) 33.33  (0.00)
Coughing: EOT(n= 262, 246) 35.75  (27.03) 38.48  (26.95)
Coughing: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 33.33 [1]   (NA)
Coughing: Survival FU 1 (n= 2, 1) 50.00  (23.57) 33.33 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
27.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Dysphagia: Baseline (n= 387, 406) 6.20  (17.52) 5.09  (15.05)
Dysphagia: C2D1(n= 336, 358) 10.22  (21.50) 6.42  (15.75)
Dysphagia: C3D1(n= 251, 301) 9.16  (20.87) 5.43  (14.53)
Dysphagia: C4D1(n= 217, 272) 8.60  (19.45) 5.88  (16.39)
Dysphagia: C5D1(n= 163, 236) 6.75  (16.63) 6.64  (16.79)
Dysphagia: C6D1(n= 147, 219) 6.80  (15.58) 4.72  (13.28)
Dysphagia: C7D1(n= 87, 187) 4.21  (11.14) 5.70  (15.17)
Dysphagia: C8D1(n=70, 167) 5.71  (12.65) 4.79  (12.82)
Dysphagia: C9D1(n= 50, 151) 1.33  (6.60) 4.64  (14.42)
Dysphagia: C10D1(n= 47, 143) 1.42  (6.80) 5.36  (15.14)
Dysphagia: C11D1(n= 37, 130) 1.80  (7.64) 2.82  (11.01)
Dysphagia: C12D1(n= 29, 129) 2.30  (8.60) 3.88  (12.93)
Dysphagia: C13D1(n= 19, 121) 0.00  (0.00) 3.86  (11.54)
Dysphagia: C14D1(n= 18, 119) 5.56  (12.78) 5.04  (13.47)
Dysphagia: C15D1(n= 16, 110) 0.00  (0.00) 3.33  (11.01)
Dysphagia: C16D1(n= 13, 106) 0.00  (0.00) 3.77  (12.45)
Dysphagia: C17D1(n= 11, 95) 3.03  (10.05) 3.86  (13.63)
Dysphagia: C18D1(n= 10, 90) 0.00  (0.00) 4.44  (15.96)
Dysphagia: C19D1(n= 9, 82) 3.70  (11.11) 5.28  (15.24)
Dysphagia: C20D1(n= 9, 78) 0.00  (0.00) 4.70  (12.85)
Dysphagia: C21D1(n= 9, 73) 0.00  (0.00) 5.02  (15.39)
Dysphagia: C22D1(n= 8, 67) 0.00  (0.00) 2.99  (11.21)
Dysphagia: C23D1(n= 8, 64) 0.00  (0.00) 3.65  (12.05)
Dysphagia: C24D1(n= 5, 62) 0.00  (0.00) 4.84  (15.79)
Dysphagia: C25D1(n= 3, 58) 0.00  (0.00) 4.02  (15.39)
Dysphagia: C26D1(n= 3, 53) 0.00  (0.00) 4.40  (13.14)
Dysphagia: C27D1(n= 3, 50) 0.00  (0.00) 2.67  (11.35)
Dysphagia: C28D1(n= 2, 46) 0.00  (0.00) 4.35  (15.09)
Dysphagia: C29D1(n= 2, 38) 0.00  (0.00) 4.39  (13.80)
Dysphagia: C30D1(n= 1, 31) 0.00 [1]   (NA) 5.38  (15.15)
Dysphagia: C31D1(n= 0, 24) NA [2]   (NA) 5.56  (21.23)
Dysphagia: C32D1(n= 0, 23) NA [2]   (NA) 7.25  (17.28)
Dysphagia: C33D1(n= 0,16) NA [2]   (NA) 6.25  (13.44)
Dysphagia: C34D1(n= 0, 14) NA [2]   (NA) 9.52  (20.38)
Dysphagia: C35D1(n= 0, 11) NA [2]   (NA) 3.03  (10.05)
Dysphagia: C36D1(n= 0, 8) NA [2]   (NA) 4.17  (11.78)
Dysphagia: C37D1(n= 0, 5) NA [2]   (NA) 6.67  (14.91)
Dysphagia: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Dysphagia: EOT(n= 264, 245) 10.23  (20.77) 8.98  (18.87)
Dysphagia: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 0.00 [1]   (NA)
Dysphagia: Survival FU 1 (n= 2, 1) 0.00  (0.00) 0.00 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
28.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Dyspnea: Baseline (n= 386, 407) 28.55  (23.21) 26.78  (22.43)
Dyspnea: C2D1(n= 335, 361) 28.14  (23.48) 28.79  (23.67)
Dyspnea: C3D1(n= 252, 301) 28.13  (22.45) 25.40  (20.60)
Dyspnea: C4D1(n= 220, 273) 27.75  (19.85) 25.17  (21.14)
Dyspnea: C5D1(n= 165, 236) 26.57  (19.61) 24.72  (19.90)
Dyspnea: C6D1(n= 148, 221) 29.69  (21.94) 24.01  (21.09)
Dyspnea: C7D1(n= 87, 187) 25.35  (21.07) 24.42  (21.23)
Dyspnea: C8D1(n=70, 167) 28.02  (24.12) 24.42  (22.33)
Dyspnea: C9D1(n= 50, 151) 26.00  (21.49) 22.44  (21.87)
Dyspnea: C10D1(n= 47, 143) 27.42  (22.56) 22.18  (21.35)
Dyspnea: C11D1(n= 37, 130) 22.67  (19.79) 20.43  (21.44)
Dyspnea: C12D1(n= 30, 129) 22.41  (18.94) 22.27  (20.47)
Dyspnea: C13D1(n= 19, 121) 16.37  (15.87) 22.22  (21.52)
Dyspnea: C14D1(n= 18, 119) 17.90  (12.13) 22.41  (20.66)
Dyspnea: C15D1(n= 16, 110) 15.28  (12.75) 22.12  (18.71)
Dyspnea: C16D1(n= 13, 106) 14.53  (13.13) 21.91  (20.71)
Dyspnea: C17D1(n= 10, 95) 18.89  (14.86) 23.51  (21.84)
Dyspnea: C18D1(n= 10, 90) 20.00  (12.61) 22.65  (21.97)
Dyspnea: C19D1(n= 9, 82) 18.52  (13.61) 22.09  (20.91)
Dyspnea: C20D1(n= 9, 78) 20.37  (15.21) 22.65  (21.37)
Dyspnea: C21D1(n= 9, 73) 19.75  (15.49) 20.40  (19.69)
Dyspnea: C22D1(n= 8, 67) 18.06  (20.52) 19.90  (17.68)
Dyspnea: C23D1(n= 8, 64) 16.67  (13.28) 21.2  (19.13)
Dyspnea: C24D1(n= 5, 62) 20.00  (14.49) 21.33  (20.94)
Dyspnea: C25D1(n= 3, 58) 29.63  (25.66) 19.73  (18.39)
Dyspnea: C26D1(n= 3, 53) 22.22  (11.11) 21.80  (19.97)
Dyspnea: C27D1(n= 3, 50) 18.52  (6.41) 20.33  (20.87)
Dyspnea: C28D1(n= 2, 46) 5.56  (7.86) 18.36  (17.87)
Dyspnea: C29D1(n= 2, 38) 5.56  (7.86) 19.30  (16.48)
Dyspnea: C30D1(n= 1, 31) 11.11 [1]   (NA) 17.92  (17.14)
Dyspnea: C31D1(n= 0, 24) NA [2]   (NA) 24.07  (18.73)
Dyspnea: C32D1(n= 0, 23) NA [2]   (NA) 24.15  (20.00)
Dyspnea: C33D1(n= 0,16) NA [2]   (NA) 25.69  (27.13)
Dyspnea: C34D1(n= 0, 14) NA [2]   (NA) 27.78  (22.96)
Dyspnea: C35D1(n= 0, 11) NA [2]   (NA) 26.26  (19.42)
Dyspnea: C36D1(n= 0, 8) NA [2]   (NA) 18.06  (13.20)
Dyspnea: C37D1(n= 0, 5) NA [2]   (NA) 24.44  (4.97)
Dyspnea: C38D1(n= 0, 2) NA [2]   (NA) 16.67  (7.86)
Dyspnea: EOT(n= 263, 246) 36.12  (24.82) 34.51  (26.36)
Dyspnea: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 22.22 [1]   (NA)
Dyspnea: Survival FU 1 (n= 2, 1) 66.67  (15.71) 44.44 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
29.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Hemoptysis: Baseline (n= 386, 406) 4.32  (13.32) 3.86  (12.12)
Hemoptysis: C2D1(n= 336, 359) 4.76  (14.24) 3.16  (10.97)
Hemoptysis: C3D1(n= 251, 301) 4.38  (13.11) 3.10  (11.12)
Hemoptysis: C4D1(n= 220, 270) 2.88  (10.89) 2.10  (9.94)
Hemoptysis: C5D1(n= 163, 234) 1.43  (7.72) 1.42  (6.76)
Hemoptysis: C6D1(n= 148, 219) 1.80  (7.56) 1.22  (6.27)
Hemoptysis: C7D1(n= 87, 187) 1.15  (6.12) 1.43  (6.76)
Hemoptysis: C8D1(n=70, 166) 1.90  (9.64) 2.41  (10.09)
Hemoptysis: C9D1(n= 50, 151) 2.00  (8.00) 1.77  (7.49)
Hemoptysis: C10D1(n= 47, 143) 2.84  (9.40) 0.70  (4.79)
Hemoptysis: C11D1(n= 37, 130) 1.80  (7.64) 1.03  (5.78)
Hemoptysis: C12D1(n= 30, 129) 0.00  (0.00) 1.03  (5.80)
Hemoptysis: C13D1(n= 19, 121) 3.51  (10.51) 1.10  (5.98)
Hemoptysis: C14D1(n= 18, 119) 1.85  (7.86) 1.68  (7.32)
Hemoptysis: C15D1(n= 16, 110) 0.00  (0.00) 1.82  (10.91)
Hemoptysis: C16D1(n= 13, 106) 0.00  (0.00) 2.83  (10.41)
Hemoptysis: C17D1(n= 11, 94) 0.00  (0.00) 2.84  (12.61)
Hemoptysis: C18D1(n= 10, 90) 0.00  (0.00) 2.96  (12.88)
Hemoptysis: C19D1(n= 9, 82) 0.00  (0.00) 2.03  (12.11)
Hemoptysis: C20D1(n= 9, 78) 0.00  (0.00) 2.56  (12.90)
Hemoptysis: C21D1(n= 8, 73) 0.00  (0.00) 1.83  (7.64)
Hemoptysis: C22D1(n= 8, 67) 0.00  (0.00) 1.99  (9.85)
Hemoptysis: C23D1(n= 8, 64) 0.00  (0.00) 1.04  (5.85)
Hemoptysis: C24D1(n= 5, 61) 0.00  (0.00) 2.73  (11.05)
Hemoptysis: C25D1(n= 3, 58) 0.00  (0.00) 3.45  (13.52)
Hemoptysis: C26D1(n= 3, 53) 0.00  (0.00) 3.77  (14.11)
Hemoptysis: C27D1(n= 3, 50) 0.00  (0.00) 2.00  (8.00)
Hemoptysis: C28D1(n= 2, 46) 33.33  (47.14) 1.45  (6.87)
Hemoptysis: C29D1(n= 2, 38) 0.00  (0.00) 0.88  (5.41)
Hemoptysis: C30D1(n= 1, 31) 0.00 [1]   (NA) 1.08  (5.99)
Hemoptysis: C31D1(n= 0, 24) NA [2]   (NA) 2.78  (9.41)
Hemoptysis: C32D1(n= 0, 23) NA [2]   (NA) 2.90  (9.60)
Hemoptysis: C33D1(n= 0,16) NA [2]   (NA) 0.00  (0.00)
Hemoptysis: C34D1(n= 0, 14) NA [2]   (NA) 0.00  (0.00)
Hemoptysis: C35D1(n= 0, 11) NA [2]   (NA) 0.00  (0.00)
Hemoptysis: C36D1(n= 0, 8) NA [2]   (NA) 4.17  (11.78)
Hemoptysis: C37D1(n= 0, 5) NA [2]   (NA) 0.00  (0.00)
Hemoptysis: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Hemoptysis: EOT(n= 264, 243) 5.18  (14.33) 6.04  (16.60)
Hemoptysis: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 0.00 [1]   (NA)
Hemoptysis: Survival FU 1 (n= 2, 1) 33.33  (47.14) 0.00 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
30.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pain in Arm or Shoulder: Baseline (n= 384, 405) 20.49  (28.85) 20.16  (27.09)
Pain in Arm or Shoulder: C2D1(n= 332, 358) 19.58  (27.45) 18.34  (26.56)
Pain in Arm or Shoulder: C3D1(n= 248, 294) 17.20  (27.16) 16.44  (25.50)
Pain in Arm or Shoulder: C4D1(n= 217, 270) 14.75  (23.74) 18.15  (26.57)
Pain in Arm or Shoulder: C5D1(n= 164, 232) 16.06  (24.06) 14.94  (23.76)
Pain in Arm or Shoulder: C6D1(n= 147, 219) 15.42  (23.17) 15.68  (24.37)
Pain in Arm or Shoulder: C7D1(n= 86, 184) 14.73  (23.77) 16.67  (26.31)
Pain in Arm or Shoulder: C8D1(n=69, 163) 15.94  (25.95) 16.77  (25.22)
Pain in Arm or Shoulder: C9D1(n= 50, 149) 14.00  (24.36) 16.78  (25.89)
Pain in Arm or Shoulder: C10D1(n= 46, 141) 14.49  (20.67) 17.73  (27.18)
Pain in Arm or Shoulder: C11D1(n= 36, 127) 11.11  (19.52) 15.49  (26.82)
Pain in Arm or Shoulder: C12D1(n= 30, 126) 12.22  (18.54) 16.93  (26.91)
Pain in Arm or Shoulder: C13D1(n= 19, 117) 12.28  (19.91) 14.81  (22.93)
Pain in Arm or Shoulder: C14D1(n= 18, 117) 11.11  (19.80) 15.67  (22.56)
Pain in Arm or Shoulder: C15D1(n= 16, 108) 12.50  (20.64) 15.74  (24.31)
Pain in Arm or Shoulder: C16D1(n= 13, 104) 7.69  (14.62) 14.10  (23.54)
Pain in Arm or Shoulder: C17D1(n= 11, 93) 9.09  (15.57) 16.49  (25.83)
Pain in Arm or Shoulder: C18D1(n= 10, 88) 13.33  (23.31) 18.18  (25.73)
Pain in Arm or Shoulder: C19D1(n= 9, 80) 7.41  (14.70) 20.83  (29.23)
Pain in Arm or Shoulder: C20D1(n= 9, 76) 11.11  (23.57) 18.42  (25.18)
Pain in Arm or Shoulder: C21D1(n= 9, 71) 11.11  (16.67) 12.68  (19.81)
Pain in Arm or Shoulder: C22D1(n= 8, 65) 16.67  (25.20) 13.33  (21.89)
Pain in Arm or Shoulder: C23D1(n= 8, 62) 16.67  (25.20) 15.05  (22.32)
Pain in Arm or Shoulder: C24D1(n= 5, 59) 20.00  (29.81) 18.08  (24.23)
Pain in Arm or Shoulder: C25D1(n= 3, 57) 11.11  (19.24) 14.62  (21.84)
Pain in Arm or Shoulder: C26D1(n= 2, 52) 16.67  (23.57) 15.38  (22.35)
Pain in Arm or Shoulder: C27D1(n= 3, 49) 11.11  (19.24) 14.97  (23.63)
Pain in Arm or Shoulder: C28D1(n= 2, 45) 0.00  (0.00) 11.85  (19.01)
Pain in Arm or Shoulder: C29D1(n= 2, 37) 0.00  (0.00) 10.81  (22.30)
Pain in Arm or Shoulder: C30D1(n= 1, 30) 0.00 [1]   (NA) 10.00  (21.71)
Pain in Arm or Shoulder: C31D1(n= 0, 23) NA [2]   (NA) 10.14  (21.17)
Pain in Arm or Shoulder: C32D1(n= 0, 22) NA [2]   (NA) 13.64  (26.55)
Pain in Arm or Shoulder: C33D1(n= 0, 15) NA [2]   (NA) 20.00  (27.60)
Pain in Arm or Shoulder: C34D1(n= 0, 14) NA [2]   (NA) 16.67  (28.49)
Pain in Arm or Shoulder: C35D1(n= 0, 11) NA [2]   (NA) 27.27  (32.72)
Pain in Arm or Shoulder: C36D1(n= 0, 8) NA [2]   (NA) 16.67  (35.63)
Pain in Arm or Shoulder: C37D1(n= 0, 5) NA [2]   (NA) 33.33  (47.14)
Pain in Arm or Shoulder: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Pain in Arm or Shoulder: EOT(n= 264, 242) 21.72  (30.48) 23.14  (29.55)
Pain in Arm or Shoulder: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 66.67 [1]   (NA)
Pain in Arm or Shoulder: Survival FU 1 (n= 2, 1) 83.33  (23.57) 33.33 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
31.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pain in Chest: Baseline (n= 385, 403) 17.92  (25.33) 19.52  (26.49)
Pain in Chest: C2D1(n= 332, 356) 16.67  (24.65) 15.26  (22.68)
Pain in Chest: C3D1(n= 249, 296) 14.59  (21.92) 15.43  (23.42)
Pain in Chest: C4D1(n= 217, 268) 14.44  (22.37) 14.43  (23.77)
Pain in Chest: C5D1(n= 164, 233) 11.99  (18.42) 12.16  (19.82)
Pain in Chest: C6D1(n= 145, 217) 12.18  (19.96) 12.60  (21.40)
Pain in Chest: C7D1(n= 86, 184) 12.40  (19.83) 11.78  (20.91)
Pain in Chest: C8D1(n=69, 164) 10.63  (20.21) 14.02  (21.52)
Pain in Chest: C9D1(n= 49, 149) 7.48  (17.03) 10.74  (20.96)
Pain in Chest: C10D1(n= 46, 142) 5.07  (12.11) 8.45  (19.62)
Pain in Chest: C11D1(n= 36, 127) 3.70  (10.62) 9.45  (22.18)
Pain in Chest: C12D1(n= 30, 128) 3.33  (10.17) 8.85  (17.49)
Pain in Chest: C13D1(n= 19, 120) 3.51  (10.51) 7.50  (16.99)
Pain in Chest: C14D1(n= 18, 118) 5.56  (12.78) 7.63  (15.96)
Pain in Chest: C15D1(n= 16, 109) 6.25  (13.44) 8.56  (18.37)
Pain in Chest: C16D1(n= 13, 105) 5.13  (12.52) 8.25  (16.53)
Pain in Chest: C17D1(n= 11, 94) 0.00  (0.00) 8.87  (20.84)
Pain in Chest: C18D1(n= 10, 89) 6.67  (14.05) 7.49  (15.69)
Pain in Chest: C19D1(n= 9, 80) 7.41  (14.70) 7.50  (19.10)
Pain in Chest: C20D1(n= 9, 76) 3.70  (11.11) 10.09  (20.38)
Pain in Chest: C21D1(n= 9, 71) 0.00  (0.00) 7.98  (15.39)
Pain in Chest: C22D1(n= 8, 66) 4.17  (11.78) 7.58  (16.33)
Pain in Chest: C23D1(n= 8, 62) 4.17  (11.78) 7.53  (17.51)
Pain in Chest: C24D1(n= 5, 61) 0.00  (0.00) 8.20  (15.70)
Pain in Chest: C25D1(n= 3, 57) 0.00  (0.00) 8.77  (16.09)
Pain in Chest: C26D1(n= 2, 52) 0.00  (0.00) 10.90  (19.49)
Pain in Chest: C27D1(n= 3, 49) 11.11  (19.24) 8.84  (18.97)
Pain in Chest: C28D1(n= 2, 45) 0.00  (0.00) 8.15  (16.14)
Pain in Chest: C29D1(n= 2, 37) 0.00  (0.00) 8.11  (16.49)
Pain in Chest: C30D1(n= 1, 31) 0.00 [1]   (NA) 5.38  (12.46)
Pain in Chest: C31D1(n= 0, 24) NA [2]   (NA) 4.17  (11.26)
Pain in Chest: C32D1(n= 0, 23) NA [2]   (NA) 13.04  (19.43)
Pain in Chest: C33D1(n= 0, 16) NA [2]   (NA) 14.58  (24.25)
Pain in Chest: C34D1(n= 0, 14) NA [2]   (NA) 14.29  (25.20)
Pain in Chest: C35D1(n= 0, 11) NA [2]   (NA) 6.06  (13.48)
Pain in Chest: C36D1(n= 0, 8) NA [2]   (NA) 4.17  (11.78)
Pain in Chest: C37D1(n= 0, 5) NA [2]   (NA) 6.67  (14.91)
Pain in Chest: C38D1(n= 0, 2) NA [2]   (NA) 0.00  (0.00)
Pain in Chest: EOT(n= 265, 245) 18.99  (26.35) 19.46  (26.95)
Pain in Chest: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 0.00 [1]   (NA)
Pain in Chest: Survival FU 1 (n= 2, 1) 50.00  (70.71) 33.33 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
32.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Peripheral Neuropathy: Baseline (n= 386, 406) 19.26  (28.94) 19.21  (27.77)
Peripheral Neuropathy: C2D1(n= 335, 358) 25.57  (29.63) 20.02  (27.21)
Peripheral Neuropathy: C3D1(n= 250, 300) 25.60  (29.16) 17.78  (25.04)
Peripheral Neuropathy: C4D1(n= 221, 272) 28.05  (29.94) 17.77  (25.75)
Peripheral Neuropathy: C5D1(n= 165, 235) 29.29  (28.94) 18.44  (25.97)
Peripheral Neuropathy: C6D1(n= 147, 221) 31.97  (30.69) 17.50  (25.34)
Peripheral Neuropathy: C7D1(n= 86, 185) 31.01  (30.59) 18.02  (25.29)
Peripheral Neuropathy: C8D1(n=70, 167) 35.24  (26.55) 17.56  (25.30)
Peripheral Neuropathy: C9D1(n= 50, 150) 36.00  (29.23) 15.78  (24.02)
Peripheral Neuropathy: C10D1(n= 47, 143) 36.17  (30.16) 18.18  (25.86)
Peripheral Neuropathy: C11D1(n= 37, 129) 27.93  (24.23) 17.05  (24.69)
Peripheral Neuropathy: C12D1(n= 30, 129) 30.00  (25.30) 17.57  (23.96)
Peripheral Neuropathy: C13D1(n= 19, 121) 26.32  (21.02) 17.91  (25.83)
Peripheral Neuropathy: C14D1(n= 18, 119) 25.93  (21.56) 17.09  (23.72)
Peripheral Neuropathy: C15D1(n= 15, 110) 24.44  (15.26) 17.58  (21.99)
Peripheral Neuropathy: C16D1(n= 13, 105) 20.51  (16.88) 17.14  (24.07)
Peripheral Neuropathy: C17D1(n= 11, 95) 21.21  (16.82) 19.30  (26.44)
Peripheral Neuropathy: C18D1(n= 10, 90) 23.33  (22.50) 18.15  (26.52)
Peripheral Neuropathy: C19D1(n= 9, 82) 14.81  (17.57) 20.33  (26.06)
Peripheral Neuropathy: C20D1(n= 9, 78) 22.22  (23.57) 17.52  (26.17)
Peripheral Neuropathy: C21D1(n= 9, 73) 29.63  (20.03) 18.72  (25.45)
Peripheral Neuropathy: C22D1(n= 7, 66) 23.81  (16.26) 15.66  (23.55)
Peripheral Neuropathy: C23D1(n= 8, 64) 16.67  (17.82) 20.31  (22.71)
Peripheral Neuropathy: C24D1(n= 5, 62) 13.33  (18.26) 20.43  (22.87)
Peripheral Neuropathy: C25D1(n= 3, 58) 11.11  (19.24) 18.39  (20.87)
Peripheral Neuropathy: C26D1(n= 2, 53) 16.67  (23.57) 20.13  (25.60)
Peripheral Neuropathy: C27D1(n= 3, 50) 11.11  (19.24) 19.33  (24.36)
Peripheral Neuropathy: C28D1(n= 2, 46) 0.00  (0.00) 19.57  (22.85)
Peripheral Neuropathy: C29D1(n= 2, 38) 0.00  (0.00) 19.30  (22.77)
Peripheral Neuropathy: C30D1(n= 1, 31) 0.00 [1]   (NA) 20.43  (28.12)
Peripheral Neuropathy: C31D1(n= 0, 24) NA [2]   (NA) 23.61  (26.88)
Peripheral Neuropathy: C32D1(n= 0, 23) NA [2]   (NA) 18.84  (22.08)
Peripheral Neuropathy: C33D1(n= 0, 16) NA [2]   (NA) 22.92  (20.07)
Peripheral Neuropathy: C34D1(n= 0, 14) NA [2]   (NA) 19.05  (21.54)
Peripheral Neuropathy: C35D1(n= 0, 11) NA [2]   (NA) 15.15  (17.41)
Peripheral Neuropathy: C36D1(n= 0, 8) NA [2]   (NA) 8.33  (15.43)
Peripheral Neuropathy: C37D1(n= 0, 5) NA [2]   (NA) 26.67  (27.89)
Peripheral Neuropathy: C38D1(n= 0, 2) NA [2]   (NA) 16.67  (23.57)
Peripheral Neuropathy: EOT(n= 262, 244) 31.81  (31.53) 19.54  (27.32)
Peripheral Neuropathy: Pro Week 6 Pd(n= 0,1) NA [2]   (NA) 66.67 [1]   (NA)
Peripheral Neuropathy: Survival FU 1 (n= 2, 1) 50.00  (23.57) 33.33 [1]   (NA)
[1]
Data not reported because SD was non-estimable since only 1 participant was evaluated for this category.
[2]
Data not reported because no participant was evaluated for this category
33.Secondary Outcome
Title EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Hide Description QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
Time Frame Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.
Arm/Group Title Docetaxel Atezolizumab
Hide Arm/Group Description:
Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Overall Number of Participants Analyzed 425 425
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pain in Other Parts: Baseline (n= 373, 402) 27.52  (30.41) 27.94  (31.52)
Pain in Other Parts: C2D1(n= 320, 347) 29.58  (30.44) 27.76  (30.53)
Pain in Other Parts: C3D1(n= 239, 286) 22.87  (27.79) 25.87  (29.79)
Pain in Other Parts: C4D1(n= 211, 263) 21.48  (26.86) 23.45  (26.92)
Pain in Other Parts: C5D1(n= 154, 230) 21.21  (26.63) 22.32  (27.24)
Pain in Other Parts: C6D1(n= 139, 214) 22.78  (25.39) 21.50  (27.88)
Pain in Other Parts: C7D1(n= 81, 180) 23.05  (28.21) 24.63  (29.56)
Pain in Other Parts: C8D1(n=65, 158) 24.10  (28.57) 18.35  (24.54)
Pain in Other Parts: C9D1(n= 44, 135) 18.18  (28.26) 21.48  (28.35)
Pain in Other Parts: C10D1(n= 44, 136) 15.15  (23.24) 21.57  (28.84)
Pain in Other Parts: C11D1(n= 34, 123) 14.71  (23.49)