Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva Lung Cancer NSCLC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 137
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity. arm 2: Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.

Interventions: intervention 1: Erlotinib HCl intervention 2: MetMAb intervention 3: placebo (0.9 % saline)
Intervention descriptions: intervention 1: Erlotinib 150 mg oral dose once daily. intervention 2: MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks. intervention 3: Placebo Intravenous infusion every 3 weeks.

Protocol document: