A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
NCT ID: NCT01519804
Last Updated: 2016-09-02
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
PHASE2
108 participants
INTERVENTIONAL
2012-04-30
2015-09-30
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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MetMAb+paclitaxel+platinum
cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Placebo+paclitaxel+platinum
Placebo
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Interventions
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Placebo
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
onartuzumab
15 mg/kg iv, Day 1 of each 21-day cycle
paclitaxel
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Bakersfield, California, United States
Fullerton, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Sacramento, California, United States
San Luis Obispo, California, United States
Santa Barbara, California, United States
Stanford, California, United States
Grand Junction, Colorado, United States
Boynton Beach, Florida, United States
Orlando, Florida, United States
Weston, Florida, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Harvey, Illinois, United States
Fort Wayne, Indiana, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Muncie, Indiana, United States
Metairie, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Hickory, North Carolina, United States
Cleveland, Ohio, United States
Middletown, Ohio, United States
Bend, Oregon, United States
Pittsburgh, Pennsylvania, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
La Rioja, , Argentina
Santa Rosa, , Argentina
Grenoble, , France
Lyon, , France
Paris, , France
Rennes, , France
Berlin, , Germany
Göttingen, , Germany
Halle, , Germany
Immenhausen, , Germany
München, , Germany
Münster, , Germany
Afula, , Israel
Ashkelon, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Avellino, Campania, Italy
Napoli, Campania, Italy
Udine, Friuli Venezia Giulia, Italy
Cremona, Lombardy, Italy
Milan, Lombardy, Italy
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Pamplona, Navarre, Spain
Zaragoza, Zaragoza, Spain
Aberdeen, , United Kingdom
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
Leeds, , United Kingdom
Countries
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Other Identifiers
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GO27820
Identifier Type: -
Identifier Source: org_study_id
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