A phase III, multicenter, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy of bevacizumab in combination with Tarceva (erlotinib) compared with Tarceva alone for treatment of advanced Non Small Cell Lung Cancer (NSCLC) after failure of standard first-Line chemotherapy - ND

• Conditions: Advanced Non Small Cell Lung Cancer (NSCLC) after failure of standard first-line chemotherapy; MedDRA version: 9.1Level: LLTClassification code 10029515Term: Non-small cell lung cancer recurrent

• Registration Number: EUCTR2006-006626-26-IT
• Lead Sponsor: GENENTECH , INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Patients must fulfill all of the following criteria to be eligible for study entry: 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. Patients who consent to provide tissue but whose archival tissue is found to be inadequate (e.g., stained slides) remain eligible for study participation ECOG performance status of 0, 1, or 2 (see Appendix F) Age >= 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria will be ineligible for study entry: Squamous cell carcinoma, except for patients with no intrathoracic disease or small peripheral lesions only Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent Systemic chemotherapy, radiotherapy, or investigational treatment within 28 days prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified