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