A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab (Avastin) Plus Platinum And Paclitaxel or With Pemetrexed Plus Platinum in Patients With Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT01496742
Last Updated: 2016-09-23
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
259 participants
INTERVENTIONAL
2012-04-30
2015-11-30
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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Bevacizumab+MetMAb
RO5490258
15 mg/kg iv, Day 1 of each 21-day cycle
bevacizumab [Avastin]
15 mg/kg 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
Bevacizumab+Placebo
Placebo
Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
bevacizumab [Avastin]
15 mg/kg 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
Pemetrexed+MetMAb
RO5490258
15 mg/kg iv, Day 1 of each 21-day cycle
cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
pemetrexed
500 mg/m2, Day 1 of each 21-day cycle
Pemetrexed+Placebo
Placebo
Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
cisplatin/carboplatin
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
pemetrexed
500 mg/m2, Day 1 of each 21-day cycle
Interventions
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Placebo
Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
RO5490258
15 mg/kg iv, Day 1 of each 21-day cycle
bevacizumab [Avastin]
15 mg/kg 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
pemetrexed
500 mg/m2, Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed Stage IIIB or Stage IV non-squamous non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* For patients who received prior adjuvant chemotherapy or chemoradiotherapy: a treatment-free interval of at least 12 months since last chemotherapy or chemoradiotherapy cycle
* Adequate tissue for central immunohistochemical (IHC) assay of Met receptor, and epidermal growth factor receptor (EGFR) testing if EGFR status is unknown
* Radiographic evidence of disease
Exclusion Criteria
* Evidence of mixed NSCLC with a predominance of the squamous cell type
* Prior exposure to experimental treatment targeting either the hepatocyte growth factor (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, unless that treatment is unavailable or refused by the patient
* Known central nervous system (CNS) disease, other than stable, treated brain metastases
* History of another malignancy in the previous 3 years, except for history of in situ cancer that was treated surgically with curative intent, localized prostate cancer that has been treated surgically with curative intent, or basal or squamous cell skin cancer
* Uncontrolled diabetes
* Pregnant or lactating women
* 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
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
Hollywood, Florida, United States
Orlando, Florida, United States
Lawrenceville, Georgia, United States
Marietta, Georgia, 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
Minneapolis, Minnesota, United States
Las Vegas, Nevada, United States
New York, New York, United States
Hickory, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Bend, Oregon, United States
Portland, Oregon, United States
Seattle, Washington, United States
Buenos Aires, , Argentina
La Rioja, , Argentina
Santa Rosa, , Argentina
Grenoble, , France
Paris, , France
Paris, , France
Rennes, , France
Göttingen, , Germany
Halle, , Germany
Immenhausen, , Germany
München, , Germany
Münster, , Germany
Afula, , Israel
Ashkelon, , Israel
Holon, , Israel
Tel Aviv, , Israel
Ẕerifin, , Israel
Avellino, Campania, Italy
Udine, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Cremona, Lombardy, Italy
Milan, Lombardy, Italy
Orbassano, Piedmont, Italy
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Riga, , Latvia
George Town, , Malaysia
Kuala Lumpur, , Malaysia
Negeri Sembilan, , Malaysia
Pulau Pinang, , Malaysia
Tanjung Bungah, , Malaysia
Aguascalientes, , Mexico
Chihuahua City, , Mexico
León, , Mexico
Cebu City, , Philippines
Davao City, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
Quezon City, , Philippines
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Pamplona, Navarre, Spain
Zaragoza, Zaragoza, Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Aberdeen, , United Kingdom
Birmingham, , United Kingdom
Bournemouth, , United Kingdom
Leeds, , United Kingdom
Manchester, , United Kingdom
Countries
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Other Identifiers
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2011-003719-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27821
Identifier Type: -
Identifier Source: org_study_id
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