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

NCT00130728 | Completed Phase 3 Results

• 1 other identifier: OSI3364g
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 4

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

Keywords

NSCLC; Avastin; Tarceva; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) Among All Randomized Patients

  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.

  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)

Secondary Outcomes (3)

• Progression-free Survival (PFS)

  From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)

• Percentage of Participants With Objective Response

  The median duration of Objective response was up to 9.7 months

• Duration of Objective Response

  Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)

Study Arms (2)

erlotinib HCl + bevacizumab

EXPERIMENTAL

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

Drug: bevacizumab

erlotinib HCl + placebo

PLACEBO COMPARATOR

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

Drug: erlotinib HCl; Drug: placebo

Interventions

bevacizumab DRUG

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

erlotinib HCl + bevacizumab

erlotinib HCl DRUG

oral erlotinib HCl 150 mg/day orally

erlotinib HCl + placebo

placebo DRUG

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

erlotinib HCl + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Kaiser Permanente - Vallejo

Vallejo, California, 94589, United States

Location

University Cancer & Blood Center, LLC; Research

Athens, Georgia, 30607, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

Annapolis, Maryland, 21401, United States

Location

Related Publications (1)

• 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.

  PMID: 21621716 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications Specialist
• Organization: Genentech, Inc.

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 16, 2005
• Study Start: June 8, 2005
• Primary Completion: July 15, 2008
• Study Completion: December 23, 2019
• Last Updated: January 14, 2021
• Results First Posted: November 3, 2011

Record last verified: 2020-12

Locations

US (4)