Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT01471197
Last Updated: 2014-05-12
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
9 participants
INTERVENTIONAL
2012-07-31
2013-02-28
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
NONE
Study Groups
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Arm 1: Ipilimumab
Ipilimumab
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
Arm 2: Pemetrexed
Pemetrexed
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Interventions
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Ipilimumab
Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
Pemetrexed
IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Recurrent/Stage IV Non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Not progressing after 4 cycles of a platinum-based first line chemotherapy
Exclusion Criteria
* Autoimmune Diseases
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Marin Specialty Care, Inc.
Greenbrae, California, United States
Medical And Surgical Specialists, Llc
Galesburg, Illinois, United States
Quincy Medical Group
Quincy, Illinois, United States
Montgomery Cancer Center
Mount Sterling, Kentucky, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
Carolina Biooncology Institute
Huntersville, North Carolina, United States
Blue Ridge Cancer Care
Christiansburg, Virginia, United States
Local Institution
Bruges, , Belgium
Local Institution
Sint-Niklaas, , Belgium
Local Institution
Paris, , France
Local Institution
Hamburg, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Benidorm-Alicante, , Spain
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-000732-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA184-124 ST
Identifier Type: -
Identifier Source: org_study_id
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