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

NCT ID: NCT00130728

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 636 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-08
• Study Completion Date: 2019-12-23

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study 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

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

erlotinib HCl

Intervention Type: DRUG

oral erlotinib HCl 150 mg/day orally

placebo

Intervention Type: DRUG

intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Interventions

bevacizumab

intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle

Intervention Type: DRUG

erlotinib HCl

oral erlotinib HCl 150 mg/day orally

Intervention Type: DRUG

placebo

intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Intervention Type: DRUG

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
• Evidence of bleeding diathesis or coagulopathy or other serious or acute internal bleeding within 6 months prior to randomization
• Central Nervous System (CNS) bleeding; history or clinical evidence of CNS stroke (hemorrhagic or thrombotic) within the last 6 months
• Progressive neurologic symptoms in patients with a history of brain metastases
• Full-dose anticoagulation with warfarin
• Chronic daily use of aspirin or other full-dose nonsteroidal anti-inflammatory drugs (NSAIDs) with anti-platelet activity
• In-patient surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
• Minor surgical procedure, fine needle aspirations or core biopsy within 7 days prior to randomization
• Anticipation of need for a major surgical procedure during the course of the study
• Serious, non-healing wound, ulcer, or bone fracture
• Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
• Pregnancy or breast-feeding
• Presence of another invasive cancer within 5 years prior to randomization
• Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Kaiser Permanente - Vallejo

Vallejo, California, United States

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

Annapolis, Maryland, United States

Countries

United States

References

Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet. 2011 May 28;377(9780):1846-54. doi: 10.1016/S0140-6736(11)60545-X.

Reference Type: DERIVED

PMID: 21621716 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

OSI3364g

Identifier Type: -

Identifier Source: org_study_id