NCT00806923

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

A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,044 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
DRUG	Gemcitabine	1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
DRUG	Placebo	iv on day 1 of each 3 week cycle until disease progression
DRUG	bevacizumab [Avastin]	15mg/kg 1v on day 1 of each 3 week cycle until disease progression
DRUG	bevacizumab [Avastin]	7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression

Timeline

• Start date: 2005-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-12-11
• Last updated: 2016-11-02

Locations

154 sites across 20 countries: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Poland, Russia, Spain, Taiwan, Thailand, United Kingdom