A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;

• adequate liver and kidney function;

• women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion Criteria:

• prior chemotherapy or treatment with another systemic cancer therapy;

• surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;

• brain metastasis or spinal cord compression;

• fertile men, and women of childbearing potential, not using adequate contraception;

• treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.