We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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
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

  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
No text entered.

  More Information