NCT01456325

A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. 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	Erlotinib	Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
DRUG	Onartuzumab (MetMab)	Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
DRUG	Placebo	Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2011-10-20
• Last updated: 2016-11-02

Locations

213 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Croatia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Peru, Poland, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom