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

• Status: Completed
• Trial end date: 2019-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Bevacizumab; Erlotinib Hydrochloride

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