Safety and Efficacy Trial of Ipilimumab Versus Pemetrexed in Non-Squamous Non-Small Cell Lung Cancer

Part of paid clinical trials in Greenbrae, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01471197
Phase
PHASE2
Status
Terminated

Conditions

  • Lung Cancer - Non Small Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — BIOLOGICAL
    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 — BIOLOGICAL
    IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.

Study Details

The purpose of this trial is to determine whether Ipilimumab will prolong survival when compared to Pemetrexed in subjects with nonsquamous, non-small cell lung cancer.

Key Dates

Start date
Jul 31, 2012
Status verified
Apr 2014
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Ipilimumab
  • Active Comparator: Arm 2: Pemetrexed

Primary Outcome Measure

Overall Survival of Participants During the Study - All Treated Participants [ Time Frame: Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started ]

Locations (7)

FacilityCityStateZIPSite coordinators
Marin Specialty Care, Inc.GreenbraeCalifornia94904-
Medical And Surgical Specialists, LlcGalesburgIllinois61401-
Quincy Medical GroupQuincyIllinois62301-
Montgomery Cancer CenterMount SterlingKentucky40353-
Meritus Center For Clinical ResearchHagerstownMaryland21742-
Carolina Biooncology InstituteHuntersvilleNorth Carolina28078-
Blue Ridge Cancer CareChristiansburgVirginia24073-

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