A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer Read More

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• No prior chemotherapy for squamous NSCLC
• Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
• Radiographic evidence of disease

Exclusion Criteria:

• Prior systemic treatment for Stage IIIB or IV squamous NSCLC
• NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
• Prior exposure to experimental treatment targeting either the HGF or Met pathway
• Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
• Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
• History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
• Pregnant or lactating women
• Uncontrolled diabetes
• Impaired bone marrow, liver or renal function as defined by protocol
• Significant history of cardiovascular disease
• Positive for HIV infection