A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

Summary

This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.

Timeline

Start

2009-04

Primary completion

2010-11

Completion

2012-01

Outcome

Mixed primary results

registry MetMAb + Erlotinib vs Placebo + Erlotinib; p = 0.6873; Hazard Ratio (HR) 1.086 (95% CI 0.727 to 1.622); Log Rank NCT00854308 ↗

registry MetMAb + Erlotinib vs Placebo + Erlotinib; p = 0.0418; Hazard Ratio (HR) 0.529 (95% CI 0.284 to 0.986); Log Rank NCT00854308 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Onartuzumab	Monoclonal antibody	15 mg/kg	Intravenous

Indications