CompletedPhase 3NCT00130728

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

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.

Checked against the public recordLast updated Jan 14, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations4
SponsorGenentech, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Genentech, Inc.
Interventions being studied
Drug: bevacizumab; Drug: erlotinib HCl; Drug: placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Kaiser Permanente - VallejoVallejo, California
  • University Cancer & Blood Center, LLC; ResearchAthens, Georgia
  • University of Kansas Medical CenterKansas City, Kansas
  • Anne Arundel Health System Research Instit-Annapolis Oncology CtrAnnapolis, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 14, 2021. Always confirm current availability with the study team.

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