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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
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

  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.
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Reporting Groups
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  
[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  
[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) ]

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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