Status:
COMPLETED
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresecta...
Eligibility Criteria
Inclusion
- Adult patient, \>/= 18 years of age
- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
- No prior treatment for unresectable Stage IIIB or IV NSCLC
- Measurable radiographic evidence of disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
- Exposure to an investigational or marketed agent that can act by EGFR inhibition
- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
- Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for \>/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for \>/= 14 days prior to randomization are eligible.
- History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
- Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
- Inadequate hematologic, biochemical, and organ function
- Pregnant or lactating women
- Life expectancy of \< 12 weeks
- Receipt of an investigational drug within 28 days prior to initiation of study treatment
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01887886
Start Date
December 1 2013
End Date
February 1 2015
Last Update
November 2 2016
Active Locations (35)
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1
Bakersfield, California, United States, 93309
2
Fullerton, California, United States, 92835
3
Long Beach, California, United States, 90813
4
Los Angeles, California, United States, 90095-1772