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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, Inc.
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
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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 
Overall Participants Analyzed 
[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) ]

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 ]
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Measure Type Secondary
Measure Title Percentage of Participants With Objective Response
Measure Description Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.
Time Frame The median duration of Objective response was up to 9.7 months  
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.
Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.

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 
Participants Analyzed 
[Units: Participants]
 301   306 
Percentage of Participants With Objective Response 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 12.6 
 (9.1 to 16.8) 
 6.2 
 (3.8 to 9.5) 


Statistical Analysis 1 for Percentage of Participants With Objective Response
Groups [1] All groups
Method [2] Mantel Haenszel
P Value [3] 0.0068
Percentage difference [4] 6.4
95% Confidence Interval 1.8 to 11.3
[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:
  Difference in objective response rates relative to placebo arm



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