NCT01496742

A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Metmab Vs. Placebo in Combination With Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients With Untreated Stage IIIb or IV Non-Squamous NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Placebo	Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
DRUG	RO5490258	15 mg/kg iv, Day 1 of each 21-day cycle
DRUG	bevacizumab [Avastin]	15 mg/kg iv, Day 1 of each 21-day cycle
DRUG	cisplatin/carboplatin	standard dose iv, Day 1 of each 21-day cycle, 4 cycles
DRUG	paclitaxel	200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
DRUG	pemetrexed	500 mg/m2, Day 1 of each 21-day cycle

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-12-21
• Last updated: 2016-09-23

Locations

87 sites across 13 countries: United States, Argentina, France, Germany, Israel, Italy, Latvia, Malaysia, Mexico, Philippines, Spain, Taiwan, United Kingdom