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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00130728
Recruitment Status : Active, not recruiting
First Posted : August 16, 2005
Results First Posted : November 3, 2011
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Drug: bevacizumab
Drug: erlotinib HCl
Drug: placebo

  Participant Flow

  Baseline Characteristics

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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      148  46.4%      147  46.4%      295  46.4% 
Male      171  53.6%      170  53.6%      341  53.6% 

  Outcome Measures

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

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