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)

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.

Inclusion Criteria:

Patients must meet the following criteria for study entry:

• Histologically confirmed NSCLC
• Availability of a tumor specimen
• Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
• Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
• At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST

Exclusion Criteria:

• More than two prior treatments for Stage IIIB/IV
• More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
• Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
• Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
• History of serious systemic disease within the past 6 months prior to randomization
• Uncontrolled diabetes
• Major surgical procedure or significant traumatic injury within 28 days prior to randomization
• Anticipation of need for a major surgical procedure during the course of the study
• Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization
• Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy