A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab Therapy With or Without Erlotinib After Completion of Chemotherapy With Bevacizumab for the First-Line Treatment of Locally Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer

Genentech, Inc.241 sites in 1 country1,145 target enrollmentJanuary 2006

ConditionsNon-Small Cell Lung Cancer

Interventionsbevacizumab erlotinib HCl placebo

Drugsbevacizumab placebo erlotinib HCl

Overview

Phase: Phase 3
Intervention: bevacizumab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Genentech, Inc.
Enrollment: 1145
Locations: 241
Primary Endpoint: Progression-free Survival (PFS)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

November 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent Form
•Histologically or cytologically confirmed NSCLC
•Advanced NSCLC or recurrent disease
•INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
•18 years of age or older
•For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study

Exclusion Criteria

•Prior systemic chemotherapy in the metastatic setting
•Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms
•Pregnancy or lactation
•Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
•Active infection or a fever within 3 days of enrollment
•Active malignancy other than lung cancer
•Radiation therapy to sites other than whole brain within 14 days prior to enrollment
•History of gross hemoptysis within 3 months prior to enrollment
•Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors
•Inadequately controlled hypertension

Arms & Interventions

1

Intervention: bevacizumab

1

Intervention: erlotinib HCl

2

Intervention: bevacizumab

2

Intervention: placebo

Outcomes

Primary Outcomes

Progression-free Survival (PFS)

Time Frame: Approximately 3 years

PFS was defined as the length of time from randomization until documented disease progression or death from any cause, whichever occurred earlier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Data presented until cut-off date 18 July 2008.

Secondary Outcomes

Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Chemotherapy Phase(Approximately 3 years)
Number of Participants With Prospectively Identified Treatment Emergent Adverse Events (TEAE) During Post-Chemotherapy Phase(Approximately 3 years)
Number of Participants With Any Adverse Events During Post-Chemotherapy Phase(Approximately 3.5 years)
Incidence of Study Treatment Discontinuation for Reasons Other Than Disease Progression in Chemotherapy Phase(Approximately 3 years)
Incidence of Study Treatment Discontinuation(Approximately 3 years)
Overall Survival(Approximately 3.5 years)