A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

• Adult patient, >/= 18 years of age
• Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
• No prior treatment for unresectable Stage IIIB or IV NSCLC
• Measurable radiographic evidence of disease according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
• Exposure to an investigational or marketed agent that can act by EGFR inhibition
• Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
• Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.
• History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
• Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
• Inadequate hematologic, biochemical, and organ function
• Pregnant or lactating women
• Life expectancy of < 12 weeks
• Receipt of an investigational drug within 28 days prior to initiation of study treatment