Clinical Trial Detail

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

- 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

Other exclusion criteria may apply.