NCT00451906

A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,252 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Platinum-based chemotherapy	As prescribed
DRUG	Bevacizumab [Avastin]	15 mg/kg IV on Day 1 of each 3 week cycle

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-03-26
• Last updated: 2016-05-24
• Results posted: 2016-04-25

Locations

369 sites across 40 countries: Argentina, Australia, Austria, Bosnia and Herzegovina, Brazil, Canada, China, Colombia, Czechia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Hong Kong, Hungary, Iceland, Israel, Italy, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, Venezuela