Status:
COMPLETED
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 incurab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01519804
Start Date
April 1 2012
End Date
September 1 2015
Last Update
September 2 2016
Active Locations (69)
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1
Huntsville, Alabama, United States, 35805
2
Scottsdale, Arizona, United States, 85259
3
Bakersfield, California, United States, 93309
4
Fullerton, California, United States, 92835