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
NCT ID: NCT01887886
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2013-12-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Onartuzumab + Erlotinib
erlotinib
150 mg orally daily
onartuzumab
15 mg/kg IV every 3 weeks
Placebo + Erlotinib
erlotinib
150 mg orally daily
placebo
IV every 3 weeks
Interventions
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erlotinib
150 mg orally daily
onartuzumab
15 mg/kg IV every 3 weeks
placebo
IV every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Bakersfield, California, United States
Fullerton, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Luis Obispo, California, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
St Louis, Missouri, United States
Canton, Ohio, United States
Nashville, Tennessee, United States
Caen, , France
Lyon, , France
Nantes, , France
Großhansdorf, , Germany
Oldenburg, , Germany
Villingen-Schwenningen, , Germany
Ehime, , Japan
Okayama, , Japan
Yamaguchi, , Japan
Tanjung Bungah, , Malaysia
Gwangju, , South Korea
Suwon, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Countries
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Other Identifiers
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2013-000868-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28758
Identifier Type: -
Identifier Source: org_study_id