NCT01351415

A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
DRUG	Docetaxel	Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
DRUG	Erlotinib	Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
DRUG	Pemetrexed	Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.

Timeline

• Start date: 2011-06-25
• Primary completion: 2016-06-25
• Completion: 2016-06-25
• First posted: 2011-05-10
• Last updated: 2017-09-18
• Results posted: 2017-09-18

Locations

179 sites across 18 countries: United States, Argentina, Austria, Belgium, Brazil, Denmark, France, Germany, Greece, Italy, Japan, Lebanon, Mexico, Netherlands, Oman, Slovakia, Spain, United Arab Emirates