A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy

Genentech, Inc.4 sites in 1 country636 target enrollmentJune 8, 2005

ConditionsNon-Small Cell Lung Cancer

Interventionsbevacizumab erlotinib HCl placebo

Drugsbevacizumab erlotinib HCl placebo

Overview

Phase: Phase 3
Intervention: bevacizumab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Genentech, Inc.
Enrollment: 636
Locations: 4
Primary Endpoint: Overall Survival (OS) Among All Randomized Patients
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.

Registry

clinicaltrials.gov

Start Date

June 8, 2005

End Date

December 23, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent
•Cytologically or histologically confirmed NSCLC
•Clinical or radiographic progression during or after first-line chemotherapy or chemoradiotherapy for NSCLC
•Consent to provide archival tissue for analysis is required for participation in this study
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Age ≥ 18 years
•Use of an acceptable means of contraception for men and women of childbearing potential
•International normalized ratio (INR) no greater than 1.3 and an aPTT no greater than the upper limits of normal within 28 days prior to enrollment for patients not on low-molecular-weight heparin or fondaparinux

Exclusion Criteria

•Squamous cell carcinoma
•Prior treatment with an investigational or marketed inhibitor of the Epidermal Growth Factor Receptor (EGFR) pathway or anti-angiogenesis agent
•Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization
•Local palliative radiotherapy within 14 days prior to randomization or persistent adverse effects from radiotherapy that have not resolved to Grade 2 or less following completion of treatment
•Whole brain radiotherapy or stereotactic radiosurgery for brain metastases within 4 weeks of Day 0
•Neurosurgery for brain metastases within 24 weeks of Day 0
•Brain biopsy within 12 weeks of Day 0
•Current use of dexamethasone for treatment associated with brain metastases
•History of gross hemoptysis within 3 months prior to randomization unless definitively treated with surgery or radiation
•History of any of the following within 6 months prior to Day 0: serious systemic disease, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) Grade 2 or greater Congestive Heart Failure (CHF), unstable symptomatic arrhythmia requiring medication, clinically significant peripheral vascular disease, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess

Arms & Interventions

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

Intervention: bevacizumab

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

Intervention: erlotinib HCl

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

Intervention: placebo

Outcomes

Primary Outcomes

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)

Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.

Secondary Outcomes

Percentage of Participants With Objective Response(The median duration of Objective response was up to 9.7 months)
Progression-free Survival (PFS)(From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years))
Duration of Objective Response(Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months))