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A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01196078
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
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-Small Cell Lung Cancer
Interventions Drug: erlotinib [Tarceva]
Drug: vinorelbine
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Period Title: Overall Study
Started 57 57
Completed 24 20
Not Completed 33 37
Reason Not Completed
Withdrawal by Subject             3             5
Adverse Event             4             4
Protocol Violation             2             1
Lack of Efficacy             17             23
Lost to Follow-up             1             0
Death             6             4
Arm/Group Title Erlotinib Vinorelbine Total
Hide Arm/Group Description Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Total of all reporting groups
Overall Number of Baseline Participants 57 56 113
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 56 participants 113 participants
78  (4.98) 78  (5.32) 78  (5.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 56 participants 113 participants
Female
10
  17.5%
11
  19.6%
21
  18.6%
Male
47
  82.5%
45
  80.4%
92
  81.4%
1.Primary Outcome
Title Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
Hide Description CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders.
Time Frame Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Measure Type: Number
Unit of Measure: percentage of participants
22.81 8.93
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0388
Comments Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group [ECOG] status, histology status, and smoking status) as explanatory variables.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 13.88
Confidence Interval (2-Sided) 95%
-0.22 to 26.19
Estimation Comments 95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.
2.Secondary Outcome
Title Percentage of Participants Achieving Disease Control
Hide Description Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled.
Time Frame Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Measure Type: Number
Unit of Measure: percentage of participants
71.93 57.14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1061
Comments Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 14.79
Confidence Interval (2-Sided) 95%
-3.54 to 31.33
Estimation Comments 95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.
3.Secondary Outcome
Title Duration of Response Among Participants Who Achieved Either a CR or PR
Hide Description Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death.
Time Frame Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a response (CR or PR) were included in the analysis.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 13 5
Median (95% Confidence Interval)
Unit of Measure: months
10.89
(5.48 to 22.23)
8.75 [1] 
(2.75 to NA)
[1]
Upper limit of the 95% CI could not be calculated because the duration of follow-up was too short to observe enough events for complete data estimation.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9505
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Disease Progression
Hide Description Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Measure Type: Number
Unit of Measure: percentage of participants
63.16 58.93
5.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death.
Time Frame Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Median (95% Confidence Interval)
Unit of Measure: months
6.66
(4.43 to 9.05)
3.87
(2.49 to 6.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2314
Comments [Not Specified]
Method Log Rank
Comments Data were stratified by gender, ECOG status, histology status, and smoking status.
6.Secondary Outcome
Title Overall Survival: Percentage of Participants With an Progressive Disease or Death
Hide Description Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Measure Type: Number
Unit of Measure: percentage of participants
56.14 48.21
7.Secondary Outcome
Title Overall Survival: Time to Event
Hide Description Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event.
Time Frame Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 56
Median (95% Confidence Interval)
Unit of Measure: months
11.21
(6.79 to 19.57)
10.36 [1] 
(7.67 to NA)
[1]
Upper limit of the 95% CI could not be calculated because the duration of follow-up was too short to observe enough events for complete data estimation.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9894
Comments [Not Specified]
Method Log Rank
Comments Data were stratified by gender, ECOG status, histology status, and smoking status.
8.Secondary Outcome
Title Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
Hide Description The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life.
Time Frame Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
PWB, Baseline (n=56,53) 6.8  (4.0) 6.2  (3.7)
PWB, Cycle 2 (n=52,42) 8.1  (3.7) 7.5  (4.4)
PWB, Cycle 3 (n=41,28) 8.9  (4.3) 5.7  (4.2)
PWB, Cycle 4 (n=37,28) 9.4  (4.0) 7.8  (6.1)
PWB, Cycle 5 (n=30,22) 8.8  (4.3) 7.7  (5.5)
PWB, Cycle 6 (n=25,20) 9.3  (5.0) 6.4  (5.5)
PWB, End of Study (n=52,48) 10.8  (5.2) 7.8  (4.5)
SWB, Baseline (n=55,53) 15.9  (6.3) 15.2  (6.8)
SWB, Cycle 2 (n=52,40) 15.5  (6.7) 14.7  (7.2)
SWB, Cycle 3 (n=42,30) 16.0  (6.9) 16.5  (6.8)
SWB, Cycle 4 (n=37,27) 15.9  (7.0) 16.1  (7.1)
SWB, Cycle 5 (n=28,21) 15.7  (7.0) 15.1  (7.7)
SWB, Cycle 6 (n=26,18) 15.2  (7.8) 17.4  (7.1)
SWB, End of Study (n=52,47) 14.4  (7.1) 14.3  (7.6)
EWB, Baseline (n=57,55) 7.8  (3.7) 6.5  (3.4)
EWB, Cycle 2 (n=52,43) 6.7  (3.8) 5.9  (3.2)
EWB, Cycle 3 (n=42,29) 6.4  (3.5) 5.6  (2.8)
EWB, Cycle 4 (n=37,27) 7.0  (3.6) 6.0  (4.6)
EWB, Cycle 5 (n=29,21) 6.3  (3.6) 5.5  (4.7)
EWB, Cycle 6 (n=25,20) 6.5  (3.5) 4.8  (3.1)
EWB, End of Study (n=52,50) 7.1  (4.1) 6.0  (3.4)
FWB, Baseline (n=56,55) 12.3  (6.2) 13.3  (7.4)
FWB, Cycle 2 (n=51,41) 12.9  (7.1) 12.9  (7.1)
FWB, Cycle 3 (n=41,27) 13.0  (7.4) 12.9  (6.9)
FWB, Cycle 4 (n=37,26) 12.8  (7.2) 11.3  (7.8)
FWB, Cycle 5 (n=29,22) 12.7  (6.2) 12.0  (7.6)
FWB, Cycle 6 (n=25,20) 11.7  (6.4) 11.4  (6.3)
FWB, End of Study (n=51,50) 11.1  (7.2) 11.5  (7.2)
LCS, Baseline (n=56,54) 11.0  (3.2) 11.1  (3.8)
LCS, Cycle 2 (n=50,45) 10.8  (3.1) 11.2  (3.5)
LCS, Cycle 3 (n=42,30) 11.0  (3.1) 10.5  (3.2)
LCS, Cycle 4 (n=37,27) 11.3  (3.1) 10.2  (3.2)
LCS, Cycle 5 (n=28,21) 10.8  (3.0) 10.0  (3.9)
LCS, Cycle 6 (n=26,20) 10.4  (2.9) 9.9  (4.0)
LCS, End of Study (n=52,50) 11.1  (3.2) 10.8  (3.2)
9.Secondary Outcome
Title Changes in Quality of Life as Measured by the FACT Questionnaire
Hide Description The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values.
Time Frame Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 52 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
PWB, Baseline (n=51,45) 6.5  (3.8) 6.0  (3.4)
PWB, Endpoint (n=51,45) 10.8  (5.2) 7.8  (4.6)
Change in PWB (n=51,45) 4.3  (5.5) 1.8  (4.7)
SWB, Baseline (n=50,45) 15.8  (6.5) 15.4  (6.7)
SWB, Endpoint (n=50,45) 14.3  (7.2) 14.4  (7.7)
Change in SWB (n=50,45) -1.5  (4.8) -1.0  (6.0)
EWB, Baseline (n=52,48) 7.9  (3.7) 6.2  (3.2)
EWB, Endpoint (n=52,48) 7.1  (4.1) 6.0  (3.4)
Change in EWB (n=52,48) -0.8  (4.4) -0.2  (4.0)
FWB, Baseline (n=51,48) 12.6  (6.2) 13.4  (7.4)
FWB, Endpoint (n=51,48) 11.1  (7.2) 11.7  (7.2)
Change in FWB (n=51,48) -1.5  (5.1) -1.7  (6.0)
LCS, Baseline (n=51,47) 10.9  (3.3) 11.2  (4.0)
LCS, Endpoint (n=51,47) 11.2  (3.2) 10.7  (3.0)
Change in LCS (n=51,47) 0.3  (3.3) -0.4  (4.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments PWB, Baseline versus Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0060
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments SWB, Baseline versus Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6871
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments EWB Baseline versus Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5104
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments FWB, Baseline versus Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9927
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Erlotinib, Vinorelbine
Comments LCS, Baseline versus Endpoint
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3581
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
Hide Description The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values.
Time Frame Baseline and End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 52 48
Measure Type: Number
Unit of Measure: percentage of participants
PWB, Score Down (n=51,45) 7.8 22.2
PWB, No Change (n=51,45) 33.3 31.1
PWB, Score Up (n=51,45) 58.8 46.7
SWB, Score Down (n=50,45) 40.0 37.8
SWB, No Change (n=50,45) 40.0 40.0
SWB, Score Up (n=50,45) 20.0 22.2
EWB, Score Down (n=52,48) 38.5 33.3
EWB, No Change (n=52,48) 38.5 41.7
EWB, Score Up (n=52,48) 23.1 25.0
FWB, Score Down (n=51,48) 41.2 41.7
FWB, No Change (n=51,48) 33.3 35.4
FWB, Score Up (n=51,48) 25.5 22.9
LCS, Score Down (n=51,47) 17.6 31.9
LCS, No Change (n=51,47) 47.1 40.4
LCS, Score Up (n=51,47) 35.3 27.7
11.Secondary Outcome
Title Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
Hide Description The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic).
Time Frame Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 52 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Shortness of breath, Baseline (n=52,48) 1.4  (0.7) 1.4  (1.1)
Shortness of breath, Endpoint (n=52,48) 1.6  (1.0) 1.3  (0.9)
Shortness of breath, Change (n=52,48) 0.2  (0.8) -0.1  (1.2)
Weight loss, Baseline (n=51,47) 0.6  (0.8) 0.8  (1.0)
Weight loss, Endpoint (n=51,47) 0.7  (0.9) 0.6  (0.7)
Weight loss, Change (n=51,47) 0.1  (1.0) -0.2  (1.2)
Clear thinking, Baseline (n=52,48) 2.4  (1.2) 2.3  (1.3)
Clear thinking, Endpoint (n=52,48) 2.2  (1.3) 2.4  (1.3)
Clear thinking, Change (n=52,48) -0.2  (1.1) 0.1  (1.5)
Coughing, Baseline (n=52,48) 1.3  (0.6) 1.4  (1.0)
Coughing, Endpoint (n=52,48) 1.4  (0.7) 1.4  (0.8)
Coughing, Change (n=52,48) 0.1  (0.8) -0.0  (1.2)
Hair loss, Baseline (n=52,48) 0.3  (0.6) 0.6  (1.1)
Hair loss, Endpoint (n=52,48) 0.4  (0.7) 0.4  (0.6)
Hair loss, Change (n=52,48) 0.1  (0.8) -0.1  (1.2)
Good appetite, Baseline (n=52,48) 1.9  (0.9) 2.0  (1.2)
Good appetite, Endpoint (n=52,48) 1.7  (1.1) 1.7  (1.0)
Good appetite, Change (n=52,48) -0.3  (0.9) -0.4  (1.3)
Tightness in chest, Baseline (n=52,48) 1.3  (0.8) 1.2  (0.9)
Tightness in chest, Endpoint (n=52,48) 1.4  (0.8) 1.3  (1.0)
Tightness in chest, Change (n=52,48) 0.1  (0.9) 0.1  (1.2)
Easy breathing, Baseline (n=52,48) 1.7  (0.9) 1.7  (1.1)
Easy breathing, Endpoint (n=52,48) 1.7  (0.9) 1.6  (1.1)
Easy breathing, Change (n=52,48) -0.1  (1.1) -0.0  (1.3)
12.Secondary Outcome
Title Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
Hide Description The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline.
Time Frame Baseline and End of study
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description:
Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

Overall Number of Participants Analyzed 52 48
Measure Type: Number
Unit of Measure: percentage of participants
Shortness of breath, Score Down (n=52,48) 17.3 18.8
Shortness of breath, No Change (n=52,48) 51.9 58.3
Shortness of breath, Score Up (n=52,48) 30.8 22.9
Weight loss, Score Down (n=51,47) 19.6 31.9
Weight loss, No Change (n=51,47) 51.0 44.7
Weight loss, Score Up (n=51,47) 29.4 23.4
Clear thinking, Score Down (n=52,48) 26.9 27.1
Clear thinking No Change (n=52,48) 53.8 43.8
Clear thinking, Score Up (n=52,48) 19.2 29.2
Coughing, Score Down (n=52,48) 21.2 22.9
Coughing, No Change (n=52,48) 53.8 50.0
Coughing, Score Up (n=52,48) 25.0 27.1
Hair loss, Score Down (n=52,48) 13.5 18.8
Hair loss, No Change (n=52,48) 65.4 60.4
Hair loss, Score Up (n=52,48) 21.2 20.8
Good appetite, Score Down (n=52,48) 26.9 35.4
Good appetite, No Change (n=52,48) 61.5 45.8
Good appetite, Score Up (n=52,48) 11.5 18.8
Tightness in chest, Score Down (n=52,48) 17.3 22.9
Tightness in chest, No Change (n=52,48) 55.8 54.2
Tightness in chest, Score Up (n=52,48) 26.9 22.9
Easy breathing, Score Down (n=52,48) 28.8 22.9
Easy breathing, No Change (n=52,48) 48.1 58.3
Easy breathing, Score Up (n=52,48) 23.1 18.8
Time Frame Adverse Events were monitored continuously during the study treatment and for 28 days after the last intake of study medication. Only SAE were recorded during post study treatment phase and for 28 days after the last intake of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Erlotinib Vinorelbine
Hide Arm/Group Description Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.

Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.

Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal.

All-Cause Mortality
Erlotinib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   19/57 (33.33%)   14/57 (24.56%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  0/57 (0.00%)  3/57 (5.26%) 
Neutropenia * 1  0/57 (0.00%)  1/57 (1.75%) 
Cardiac disorders     
Cardiogenic shock * 1  1/57 (1.75%)  0/57 (0.00%) 
Cardiopulmonary failure * 1  1/57 (1.75%)  0/57 (0.00%) 
Cardiac arrest * 1  0/57 (0.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage * 1  1/57 (1.75%)  0/57 (0.00%) 
Melaena * 1  0/57 (0.00%)  1/57 (1.75%) 
Vomiting * 1  0/57 (0.00%)  1/57 (1.75%) 
General disorders     
Asthenia * 1  1/57 (1.75%)  0/57 (0.00%) 
Pyrexia * 1  0/57 (0.00%)  1/57 (1.75%) 
Chest Discomfort * 1  0/57 (0.00%)  1/57 (1.75%) 
Chest pain * 1  0/57 (0.00%)  1/57 (1.75%) 
Hepatobiliary disorders     
Hepatitis * 1  1/57 (1.75%)  0/57 (0.00%) 
Jaundice * 1  1/57 (1.75%)  0/57 (0.00%) 
Infections and infestations     
Urinary tract infection * 1  1/57 (1.75%)  0/57 (0.00%) 
Pneumonia * 1  4/57 (7.02%)  6/57 (10.53%) 
Herpes zoster * 1  1/57 (1.75%)  0/57 (0.00%) 
Septic shock * 1  0/57 (0.00%)  1/57 (1.75%) 
Cellulitis * 1  0/57 (0.00%)  1/57 (1.75%) 
Injury, poisoning and procedural complications     
Femoral neck fracture * 1  1/57 (1.75%)  0/57 (0.00%) 
Spinal fracture * 1  1/57 (1.75%)  0/57 (0.00%) 
Subdural haematoma * 1  0/57 (0.00%)  1/57 (1.75%) 
Metabolism and nutrition disorders     
Hypoglycaemia * 1  1/57 (1.75%)  0/57 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant melanoma * 1  1/57 (1.75%)  0/57 (0.00%) 
Nervous system disorders     
Extrapyramidal disorder * 1  1/57 (1.75%)  0/57 (0.00%) 
Parkinsonism * 1  1/57 (1.75%)  0/57 (0.00%) 
Syncope * 1  0/57 (0.00%)  1/57 (1.75%) 
Psychiatric disorders     
Alcohol withdrawal syndrome * 1  1/57 (1.75%)  0/57 (0.00%) 
Depression * 1  0/57 (0.00%)  1/57 (1.75%) 
Renal and urinary disorders     
Renal failure acute * 1  1/57 (1.75%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hiccups * 1  1/57 (1.75%)  0/57 (0.00%) 
Respiratory failure * 1  1/57 (1.75%)  1/57 (1.75%) 
Acute respiratory failure * 1  1/57 (1.75%)  0/57 (0.00%) 
Pneumonia aspiration * 1  1/57 (1.75%)  0/57 (0.00%) 
Chronic obstructive pulmonary disease * 1  0/57 (0.00%)  1/57 (1.75%) 
Dyspnoea * 1  0/57 (0.00%)  1/57 (1.75%) 
Vascular disorders     
Infarction * 1  1/57 (1.75%)  0/57 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib Vinorelbine
Affected / at Risk (%) Affected / at Risk (%)
Total   54/55 (98.18%)   53/54 (98.15%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/55 (5.45%)  1/54 (1.85%) 
Gastrointestinal disorders     
Diarrhoea * 1  20/55 (36.36%)  7/54 (12.96%) 
Mouth ulceration * 1  9/55 (16.36%)  1/54 (1.85%) 
Constipation * 1  7/55 (12.73%)  7/54 (12.96%) 
Vomiting * 1  4/55 (7.27%)  6/54 (11.11%) 
Abdominal pain upper * 1  3/55 (5.45%)  4/54 (7.41%) 
Nausea * 1  3/55 (5.45%)  5/54 (9.26%) 
Stomatitis * 1  3/55 (5.45%)  4/54 (7.41%) 
Abdominal distension * 1  2/55 (3.64%)  4/54 (7.41%) 
Gastrooesophageal reflux disease * 1  3/55 (5.45%)  0/54 (0.00%) 
General disorders     
Pyrexia * 1  3/55 (5.45%)  8/54 (14.81%) 
Fatigue * 1  1/55 (1.82%)  6/54 (11.11%) 
Oedema * 1  3/55 (5.45%)  4/54 (7.41%) 
Infections and infestations     
Conjunctivitis * 1  3/55 (5.45%)  1/54 (1.85%) 
Tinea cruris * 1  3/55 (5.45%)  0/54 (0.00%) 
Folliculitis * 1  4/55 (7.27%)  0/54 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  16/55 (29.09%)  24/54 (44.44%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/55 (5.45%)  2/54 (3.70%) 
Nervous system disorders     
Headache * 1  3/55 (5.45%)  2/54 (3.70%) 
Psychiatric disorders     
Insomnia * 1  5/55 (9.09%)  7/54 (12.96%) 
Respiratory, thoracic and mediastinal disorders     
Mucosal inflammation * 1  5/55 (9.09%)  1/54 (1.85%) 
Productive cough * 1  3/55 (5.45%)  2/54 (3.70%) 
Oropharyngeal pain * 1  3/55 (5.45%)  0/54 (0.00%) 
Rhinorrhoea * 1  2/55 (3.64%)  3/54 (5.56%) 
Hiccups * 1  3/55 (5.45%)  0/54 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash * 1  38/55 (69.09%)  3/54 (5.56%) 
Vascular disorders     
Hypertension * 1  3/55 (5.45%)  0/54 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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 after the first publication or presentation that involves the overall study. 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
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 1-800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01196078     History of Changes
Other Study ID Numbers: ML20322
First Submitted: September 3, 2010
First Posted: September 8, 2010
Results First Submitted: July 23, 2014
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015