NCT00854308

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

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib HCl	Erlotinib 150 mg oral dose once daily.
DRUG	MetMAb	MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
DRUG	placebo (0.9 % saline)	Placebo Intravenous infusion every 3 weeks.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-11-01
• Completion: 2012-01-01
• First posted: 2009-03-03
• Last updated: 2017-03-31
• Results posted: 2011-10-18