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

Status: Recruiting
Phase:
Diagnosis: Lung Cancer
NCT ID: NCT01519804 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-068

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Bruce Johnson, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Christopher G. Azzoli, MD, Massachusetts General Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

Eligibility Criteria

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
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