A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00130728
First received: August 12, 2005
Last updated: September 26, 2011
Last verified: September 2011
Results First Received: November 16, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab
Drug: erlotinib HCl
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Participant Flow:   Overall Study
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo  
STARTED     319     317  
Received Study Drug (Safety Population)     313     313  
COMPLETED     108     104  
NOT COMPLETED     211     213  
Death                 207                 211  
Lost to Follow-up                 4                 0  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
Total Total of all reporting groups

Baseline Measures
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo     Total  
Number of Participants  
[units: participants]
  319     317     636  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 10.4     65.0  ± 10.3     64.9  ± 10.4  
Age, Customized  
[units: participants]
     
Between 18 and 59 years     91     90     181  
Between 60 and 64 years     62     66     128  
Between 65 and 69 years     59     53     112  
>= 70 years     107     108     215  
Gender  
[units: participants]
     
Female     148     147     295  
Male     171     170     341  



  Outcome Measures
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1.  Primary:   Overall Survival (OS) Among All Randomized Patients   [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ]
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Measure Type Primary
Measure Title Overall Survival (OS) Among All Randomized Patients
Measure Description Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
Time Frame From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized patients

Reporting Groups
  Description
Erlotinib HCl + Bevacizumab oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Measured Values
    Erlotinib HCl + Bevacizumab     Erlotinib HCl + Placebo  
Number of Participants Analyzed  
[units: participants]
  319     317  
Overall Survival (OS) Among All Randomized Patients  
[units: months]
Median ( 95% Confidence Interval )
  9.3  
  ( 7.39 to 11.47 )  
  9.2  
  ( 7.85 to 11.60 )  


Statistical Analysis 1 for Overall Survival (OS) Among All Randomized Patients
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.7583
Hazard Ratio (HR) [4] .970
95% Confidence Interval ( 0.799 to 1.177 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  relative to placebo arm
[4] Other relevant estimation information:
  Stratified analysis; Hazard ratio is relative to placebo arm.



2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) ]

3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: The median duration of Objective response was up to 9.7 months ]

4.  Secondary:   Duration of Objective Response   [ Time Frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information