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A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]

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ClinicalTrials.gov Identifier: NCT01846416
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : December 16, 2016
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Enrollment 138
Recruitment Details  
Pre-assignment Details Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280): 2L+ Participants Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
Hide Arm/Group Description Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Period Title: Treatment Phase
Started 31 93 13
Completed 0 0 0
Not Completed 31 93 13
Reason Not Completed
Death             2             9             1
Withdrawal by Subject             2             4             2
Other             1             5             1
Physician Decision             1             2             0
Adverse Event             3             4             0
Non-compliance             0             2             0
Study Terminated by Sponsor             1             4             0
Progressive Disease             21             63             9
Period Title: Survival Follow-up
Started 28 80 12
Completed 0 0 0
Not Completed 28 80 12
Reason Not Completed
Death             21             62             9
Lost to Follow-up             0             2             2
Withdrawal by Subject             2             7             0
Study Terminated by Sponsor             2             8             0
Other             3             1             1
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants Total
Hide Arm/Group Description Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Total of all reporting groups
Overall Number of Baseline Participants 31 93 13 137
Hide Baseline Analysis Population Description
All participants who received any dose of atezolizumab during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 93 participants 13 participants 137 participants
68  (10.8) 65.2  (9.3) 63.8  (7.7) 65.7  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 93 participants 13 participants 137 participants
Female
17
  54.8%
34
  36.6%
7
  53.8%
58
  42.3%
Male
14
  45.2%
59
  63.4%
6
  46.2%
79
  57.7%
1.Primary Outcome
Title Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
Time Frame Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32
(17 to 51)
21
(13 to 30)
23
(5 to 54)
2.Secondary Outcome
Title Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
Hide Description Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.
Time Frame Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29
(14 to 48)
19
(11 to 28)
23
(5 to 54)
3.Secondary Outcome
Title Duration of Objective Response According to RECIST v1.1
Hide Description Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.
Time Frame Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population with a confirmed objective response.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 9 17 3
Median (Full Range)
Unit of Measure: months
9.2
(2.3 to 30.4)
17.0
(2.8 to 44.2)
NA [1] 
(2.8 to 9.9)
[1]
Median DOR was not reached.
4.Secondary Outcome
Title Percentage of Participants With 6-Month Duration of Objective Response
Hide Description Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population with a confirmed objective response.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 8 15 3
Measure Type: Number
Unit of Measure: percentage of participants
75.0 91.7 66.7
5.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death According to RECIST v1.1
Hide Description For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Unit of Measure: percentage of participants
67.7 74.2 84.6
6.Secondary Outcome
Title Progression-Free Survival (PFS) According to RECIST v1.1
Hide Description PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.
Time Frame Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Median (Full Range)
Unit of Measure: months
4.5
(0.9 to 37.9)
2.7
(0.0 to 45.5)
2.5
(1.0 to 11.3)
7.Secondary Outcome
Title Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Hide Description Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Time Frame Months 6, 12 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Unit of Measure: percentage of participants
Month 6 33.50 32.29 15.38
Month 12 20 23 NA [1] 
Month 30 13 10 NA [1] 
[1]
Not estimable
8.Secondary Outcome
Title Percentage of Participants With Disease Progression or Death According to Modified RECIST
Hide Description For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Time Frame Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Unit of Measure: percentage of participants
58.1 66.7 69.2
9.Secondary Outcome
Title PFS According to Modified RECIST
Hide Description PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.
Time Frame Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Median (Full Range)
Unit of Measure: months
5.5
(0.9 to 37.9)
3.7
(0.0 to 45.5)
4.3
(1.1 to 16.2)
10.Secondary Outcome
Title Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Hide Description Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Time Frame Months 6, 12 and 30
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Unit of Measure: percentage of participants
Month 6 43.12 39.10 44.87
Month 12 31 29 24
Month 30 12 10 NA [1] 
[1]
Not estimable
11.Secondary Outcome
Title Percentage of Participants With Death
Hide Description Participants were followed for survival throughout the study.
Time Frame Baseline till death or up to 20 months, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Measure Type: Number
Unit of Measure: percentage of participants
74.2 76.3 76.9
12.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.
Time Frame Baseline till death or up to 20 months, whichever occurred first
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy-evaluable population.
Arm/Group Title Atezolizumab (MPDL3280) : 1L Participants Atezolizumab (MPDL3280) : 2L+ Participants Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Hide Arm/Group Description:
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
Overall Number of Participants Analyzed 31 93 13
Median (95% Confidence Interval)
Unit of Measure: months
14.4
(12.8 to 22.1)
9.3
(5.8 to 17.6)
6.8
(3.2 to 19.5)
13.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) for Atezolizumab
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points. Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.
Arm/Group Title Atezolizumab (MPDL3280) : All Arms
Hide Arm/Group Description:
All participants included in the study were reported.
Overall Number of Participants Analyzed 135
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms per milliliter (mcg/mL)
405
(31.7%)
14.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) for Atezolizumab
Hide Description [Not Specified]
Time Frame Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.
Arm/Group Title Atezolizumab (MPDL3280) : All Arms
Hide Arm/Group Description:
All participants included in the study were reported.
Overall Number of Participants Analyzed 125
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mcg/mL
Pre-dose Cycle 2 (Day 1) (n= 125)
68.8
(55.3%)
Pre-dose Cycle 3 (Day 1) (n= 100)
90.6
(136.6%)
Pre-dose Cycle 4 (Day 1) (n= 92)
123
(136.9%)
Pre-dose Cycle 8 (Day 1) (n= 51)
206
(45.9%)
Pre-dose Cycle 16 (Day 1) (n= 1)
135 [1] 
(NA%)
[1]
Geometric co-efficient of variation was not calculated as only 1 participant was analyzed at the specified time point.
Time Frame Baseline until 20 months.
Adverse Event Reporting Description All participants who received at least one dose of atezolizumab were included in analysis.
 
Arm/Group Title Atezolizumab (MPDL3280A) : 1L Participants Atezolizumab (MPDL3280A) : 2L+ Participants Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Hide Arm/Group Description Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression. Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator. Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
All-Cause Mortality
Atezolizumab (MPDL3280A) : 1L Participants Atezolizumab (MPDL3280A) : 2L+ Participants Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Atezolizumab (MPDL3280A) : 1L Participants Atezolizumab (MPDL3280A) : 2L+ Participants Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/31 (54.84%)   46/93 (49.46%)   6/13 (46.15%) 
Blood and lymphatic system disorders       
Disseminated intravascular coagulation * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Febrile neutropenia * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Cardiac disorders       
Cardiac tamponade * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Pericardial effusion * 1  1/31 (3.23%)  2/93 (2.15%)  0/13 (0.00%) 
Atrial flutter * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Cardiac arrest * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Coronary artery disease * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Myocardial infarction * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Pericarditis constrictive * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
CARDIAC FAILURE CONGESTIVE * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
PALPITATIONS * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Endocrine disorders       
Hypothyroidism * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Thyroiditis acute * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Eye disorders       
Amaurosis fugax * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Photopsia * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  2/31 (6.45%)  1/93 (1.08%)  0/13 (0.00%) 
Abdominal pain * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Abdominal wall haematoma * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Constipation * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Lower gastrointestinal haemorrhage * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Nausea * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Rectal haemorrhage * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Vomiting * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
AUTOIMMUNE COLITIS * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
COLITIS * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
General disorders       
Chest pain * 1  0/31 (0.00%)  2/93 (2.15%)  2/13 (15.38%) 
Pain * 1  0/31 (0.00%)  2/93 (2.15%)  0/13 (0.00%) 
Pyrexia * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Hepatobiliary disorders       
HEPATIC FUNCTION ABNORMAL * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Infections and infestations       
Pneumonia * 1  3/31 (9.68%)  8/93 (8.60%)  0/13 (0.00%) 
Lower respiratory tract infection * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Upper respiratory tract infection * 1  2/31 (6.45%)  0/93 (0.00%)  0/13 (0.00%) 
Abscess neck * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Bronchitis * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Groin abscess * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Herpes zoster disseminated * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Influenza * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Sepsis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Sinusitis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Injury, poisoning and procedural complications       
Fall * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Hip fracture * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Spinal compression fracture * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Investigations       
Alanine aminotransferase increased * 1  1/31 (3.23%)  1/93 (1.08%)  0/13 (0.00%) 
Aspartate aminotransferase increased * 1  1/31 (3.23%)  1/93 (1.08%)  0/13 (0.00%) 
INFLUENZA B VIRUS TEST POSITIVE * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Metabolism and nutrition disorders       
Dehydration * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Diabetes mellitus * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Hypocalcaemia * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
HYPERKALAEMIA * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
HYPONATRAEMIA * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  2/31 (6.45%)  3/93 (3.23%)  0/13 (0.00%) 
Muscular weakness * 1  1/31 (3.23%)  1/93 (1.08%)  0/13 (0.00%) 
Arthralgia * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Bone pain * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Musculoskeletal pain * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
PAIN IN EXTREMITY * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Nervous system disorders       
Guillain-Barre Syndrome * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Intracranial venous sinus thrombosis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Monoparesis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Nervous system disorder * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Seizure * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Syncope * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Vocal cord paralysis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Psychiatric disorders       
Confusional state * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Mental status changes * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders       
Renal failure * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  1/31 (3.23%)  6/93 (6.45%)  0/13 (0.00%) 
Haemoptysis * 1  3/31 (9.68%)  2/93 (2.15%)  0/13 (0.00%) 
Pleural effusion * 1  1/31 (3.23%)  1/93 (1.08%)  0/13 (0.00%) 
Pulmonary embolism * 1  0/31 (0.00%)  2/93 (2.15%)  0/13 (0.00%) 
Pulmonary haemorrhage * 1  0/31 (0.00%)  2/93 (2.15%)  0/13 (0.00%) 
Bronchial obstruction * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Bronchostenosis * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Pneumonitis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Pulmonary hypertension * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Pulmonary oedema * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Respiratory disorder * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  1/31 (3.23%)  0/93 (0.00%)  0/13 (0.00%) 
Embolism * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Hypertension * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
Jugular vein thrombosis * 1  0/31 (0.00%)  1/93 (1.08%)  0/13 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (20.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atezolizumab (MPDL3280A) : 1L Participants Atezolizumab (MPDL3280A) : 2L+ Participants Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/31 (100.00%)   88/93 (94.62%)   13/13 (100.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  6/31 (19.35%)  19/93 (20.43%)  1/13 (7.69%) 
Neutropenia * 1  2/31 (6.45%)  2/93 (2.15%)  0/13 (0.00%) 
Thrombocytopenia * 1  1/31 (3.23%)  0/93 (0.00%)  1/13 (7.69%) 
Lymphadenopathy * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Cardiac disorders       
Tachycardia * 1  0/31 (0.00%)  3/93 (3.23%)  1/13 (7.69%) 
Atrial fibrillation * 1  2/31 (6.45%)  2/93 (2.15%)  0/13 (0.00%) 
Pericardial effusion * 1  0/31 (0.00%)  2/93 (2.15%)  1/13 (7.69%) 
Aortic valve thickening * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Ear and labyrinth disorders       
Vertigo * 1  1/31 (3.23%)  1/93 (1.08%)  1/13 (7.69%) 
EXCESSIVE CERUMEN PRODUCTION * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Deafness bilateral * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Ear pain * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Vestibular disorder * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Endocrine disorders       
Hypothyroidism * 1  1/31 (3.23%)  3/93 (3.23%)  1/13 (7.69%) 
Eye disorders       
Diplopia * 1  0/31 (0.00%)  2/93 (2.15%)  1/13 (7.69%) 
Lacrimation increased * 1  0/31 (0.00%)  2/93 (2.15%)  1/13 (7.69%) 
Vision blurred * 1  2/31 (6.45%)  1/93 (1.08%)  1/13 (7.69%) 
Periorbital oedema * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
CONJUNCTIVAL HYPERAEMIA * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
Gastrointestinal disorders       
Nausea * 1  11/31 (35.48%)  27/93 (29.03%)  4/13 (30.77%) 
Constipation * 1  8/31 (25.81%)  16/93 (17.20%)  6/13 (46.15%) 
Diarrhoea * 1  8/31 (25.81%)  17/93 (18.28%)  4/13 (30.77%) 
Vomiting * 1  4/31 (12.90%)  14/93 (15.05%)  3/13 (23.08%) 
Dysphagia * 1  2/31 (6.45%)  8/93 (8.60%)  1/13 (7.69%) 
Gastrooesophageal reflux disease * 1  2/31 (6.45%)  7/93 (7.53%)  0/13 (0.00%) 
Abdominal pain * 1  1/31 (3.23%)  7/93 (7.53%)  0/13 (0.00%) 
Dyspepsia * 1  0/31 (0.00%)  3/93 (3.23%)  1/13 (7.69%) 
Abdominal pain upper * 1  2/31 (6.45%)  5/93 (5.38%)  1/13 (7.69%) 
Mouth swelling * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
ABDOMINAL PAIN LOWER * 1  0/31 (0.00%)  3/93 (3.23%)  1/13 (7.69%) 
STOMATITIS * 1  2/31 (6.45%)  3/93 (3.23%)  0/13 (0.00%) 
General disorders       
Fatigue * 1  16/31 (51.61%)  38/93 (40.86%)  5/13 (38.46%) 
Pyrexia * 1  7/31 (22.58%)  21/93 (22.58%)  1/13 (7.69%) 
Oedema peripheral * 1  3/31 (9.68%)  14/93 (15.05%)  2/13 (15.38%) 
Chest pain * 1  1/31 (3.23%)  9/93 (9.68%)  0/13 (0.00%) 
Pain * 1  3/31 (9.68%)  2/93 (2.15%)  2/13 (15.38%) 
Asthenia * 1  1/31 (3.23%)  9/93 (9.68%)  0/13 (0.00%) 
Chills * 1  1/31 (3.23%)  5/93 (5.38%)  1/13 (7.69%) 
Influenza like illness * 1  3/31 (9.68%)  4/93 (4.30%)  1/13 (7.69%) 
Malaise * 1  0/31 (0.00%)  6/93 (6.45%)  0/13 (0.00%) 
Gait disturbance * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
General physical health deterioration * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Immune system disorders       
Drug hypersensitivity * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Infections and infestations       
Upper respiratory tract infection * 1  2/31 (6.45%)  17/93 (18.28%)  0/13 (0.00%) 
Pneumonia * 1  1/31 (3.23%)  8/93 (8.60%)  0/13 (0.00%) 
Urinary tract infection * 1  7/31 (22.58%)  3/93 (3.23%)  2/13 (15.38%) 
Candida infection * 1  2/31 (6.45%)  1/93 (1.08%)  0/13 (0.00%) 
Cystitis * 1  2/31 (6.45%)  0/93 (0.00%)  0/13 (0.00%) 
Fungal skin infection * 1  1/31 (3.23%)  1/93 (1.08%)  1/13 (7.69%) 
Influenza * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Respiratory tract infection * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
SINUSITIS * 1  2/31 (6.45%)  2/93 (2.15%)  0/13 (0.00%) 
Injury, poisoning and procedural complications       
FALL * 1  1/31 (3.23%)  6/93 (6.45%)  0/13 (0.00%) 
JAW FRACTURE * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
LACERATION * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
LIMB INJURY * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Investigations       
Weight decreased * 1  6/31 (19.35%)  9/93 (9.68%)  1/13 (7.69%) 
Alanine aminotransferase increased * 1  2/31 (6.45%)  2/93 (2.15%)  2/13 (15.38%) 
Aspartate aminotransferase increased * 1  2/31 (6.45%)  3/93 (3.23%)  2/13 (15.38%) 
LYMPHOCYTE COUNT DECREASED * 1  2/31 (6.45%)  3/93 (3.23%)  0/13 (0.00%) 
Blood alkaline phosphatase increased * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
Haemoglobin decreased * 1  1/31 (3.23%)  0/93 (0.00%)  1/13 (7.69%) 
Blood thyroid stimulating hormone increased * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders       
Decreased appetite * 1  6/31 (19.35%)  22/93 (23.66%)  2/13 (15.38%) 
Hypokalaemia * 1  2/31 (6.45%)  12/93 (12.90%)  4/13 (30.77%) 
Hyponatraemia * 1  3/31 (9.68%)  12/93 (12.90%)  0/13 (0.00%) 
Dehydration * 1  2/31 (6.45%)  7/93 (7.53%)  1/13 (7.69%) 
Hypomagnesaemia * 1  0/31 (0.00%)  8/93 (8.60%)  0/13 (0.00%) 
Hypercalcaemia * 1  2/31 (6.45%)  6/93 (6.45%)  0/13 (0.00%) 
Hypoalbuminaemia * 1  1/31 (3.23%)  6/93 (6.45%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  6/31 (19.35%)  18/93 (19.35%)  2/13 (15.38%) 
Back pain * 1  4/31 (12.90%)  19/93 (20.43%)  2/13 (15.38%) 
Pain in extremity * 1  2/31 (6.45%)  8/93 (8.60%)  1/13 (7.69%) 
Musculoskeletal pain * 1  4/31 (12.90%)  9/93 (9.68%)  1/13 (7.69%) 
Musculoskeletal chest pain * 1  1/31 (3.23%)  8/93 (8.60%)  0/13 (0.00%) 
Myalgia * 1  3/31 (9.68%)  5/93 (5.38%)  1/13 (7.69%) 
Neck pain * 1  1/31 (3.23%)  5/93 (5.38%)  0/13 (0.00%) 
Bone pain * 1  0/31 (0.00%)  3/93 (3.23%)  1/13 (7.69%) 
Muscle spasms * 1  0/31 (0.00%)  4/93 (4.30%)  1/13 (7.69%) 
FLANK PAIN * 1  0/31 (0.00%)  5/93 (5.38%)  0/13 (0.00%) 
MUSCULAR WEAKNESS * 1  2/31 (6.45%)  4/93 (4.30%)  0/13 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumour pain * 1  0/31 (0.00%)  4/93 (4.30%)  2/13 (15.38%) 
Nervous system disorders       
Headache * 1  5/31 (16.13%)  10/93 (10.75%)  3/13 (23.08%) 
Dizziness * 1  4/31 (12.90%)  8/93 (8.60%)  1/13 (7.69%) 
Dysgeusia * 1  4/31 (12.90%)  4/93 (4.30%)  0/13 (0.00%) 
Peripheral sensory neuropathy * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
Cognitive disorder * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Hemiparesis * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
Memory impairment * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
Nystagmus * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Syncope * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
PARAESTHESIA * 1  2/31 (6.45%)  4/93 (4.30%)  0/13 (0.00%) 
Psychiatric disorders       
Insomnia * 1  4/31 (12.90%)  11/93 (11.83%)  1/13 (7.69%) 
Anxiety * 1  0/31 (0.00%)  11/93 (11.83%)  2/13 (15.38%) 
Depression * 1  3/31 (9.68%)  9/93 (9.68%)  1/13 (7.69%) 
Confusional state * 1  1/31 (3.23%)  4/93 (4.30%)  1/13 (7.69%) 
Hallucination * 1  0/31 (0.00%)  2/93 (2.15%)  1/13 (7.69%) 
Reproductive system and breast disorders       
Breast swelling * 1  1/31 (3.23%)  0/93 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/31 (16.13%)  33/93 (35.48%)  3/13 (23.08%) 
Dyspnoea * 1  8/31 (25.81%)  30/93 (32.26%)  3/13 (23.08%) 
Productive cough * 1  2/31 (6.45%)  13/93 (13.98%)  0/13 (0.00%) 
Wheezing * 1  3/31 (9.68%)  7/93 (7.53%)  2/13 (15.38%) 
Dysphonia * 1  1/31 (3.23%)  6/93 (6.45%)  1/13 (7.69%) 
Haemoptysis * 1  3/31 (9.68%)  6/93 (6.45%)  1/13 (7.69%) 
Nasal congestion * 1  1/31 (3.23%)  6/93 (6.45%)  0/13 (0.00%) 
Pleural effusion * 1  2/31 (6.45%)  5/93 (5.38%)  2/13 (15.38%) 
Pulmonary embolism * 1  1/31 (3.23%)  5/93 (5.38%)  0/13 (0.00%) 
Dyspnoea exertional * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
CHRONIC OBSTRUCTIVE PULMONARY DISEASE * 1  2/31 (6.45%)  0/93 (0.00%)  0/13 (0.00%) 
OROPHARYNGEAL PAIN * 1  2/31 (6.45%)  5/93 (5.38%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  5/31 (16.13%)  9/93 (9.68%)  1/13 (7.69%) 
Dry skin * 1  1/31 (3.23%)  12/93 (12.90%)  0/13 (0.00%) 
Night sweats * 1  2/31 (6.45%)  7/93 (7.53%)  1/13 (7.69%) 
Rash * 1  3/31 (9.68%)  9/93 (9.68%)  1/13 (7.69%) 
Decubitus ulcer * 1  2/31 (6.45%)  0/93 (0.00%)  0/13 (0.00%) 
Acne * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
Dermatitis * 1  0/31 (0.00%)  1/93 (1.08%)  1/13 (7.69%) 
RASH MACULO-PAPULAR * 1  2/31 (6.45%)  3/93 (3.23%)  0/13 (0.00%) 
Vascular disorders       
Hypotension * 1  3/31 (9.68%)  9/93 (9.68%)  0/13 (0.00%) 
Hypertension * 1  3/31 (9.68%)  3/93 (3.23%)  1/13 (7.69%) 
Hot flush * 1  0/31 (0.00%)  2/93 (2.15%)  1/13 (7.69%) 
Haematoma * 1  0/31 (0.00%)  0/93 (0.00%)  1/13 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (20.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01846416    
Other Study ID Numbers: GO28625
2013-000177-69 ( EudraCT Number )
First Submitted: May 1, 2013
First Posted: May 3, 2013
Results First Submitted: October 24, 2016
Results First Posted: December 16, 2016
Last Update Posted: January 8, 2019