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

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID: NCT00130728
Run by: Genentech, Inc.
People needed: 636
Starts: 2005-06-08
Expected to finish: 2019-12-23
Last updated by the study team: 2021-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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

Full record on ClinicalTrials.gov

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