Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

Last updated: June 16, 2020
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01285609
CA184-104
2009-017396-19
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Eligibility Criteria

Inclusion

For more information regarding BMS clinical trial participation, please visitwww.BMSStudyConnect.com. Inclusion Criteria:

  • Non small cell lung cancer (NSCLC) - squamous cell

  • Stage IV or recurrent NSCLC

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

Exclusion Criteria:

  • Brain Metastases

  • Autoimmune diseases

Study Design

Total Participants: 1289
Study Start date:
January 16, 2011
Estimated Completion Date:
August 22, 2017

Study Description

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

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    Bedford Park, Sa, South Australia 5042
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    Box Hill, Victoria 3128
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    Frankston, Victoria 3199
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    Site Not Available

  • Southern Illinois University School Of Medicine

    Springfield, Illinois 62794-9678
    United States

    Site Not Available

  • St. Francis Hospital & Health Centers

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Floyd Memorial Cancer Center Of Indiana

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Kentucky Cancer Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • Montgomery Cancer Center

    Mount Sterling, Kentucky 40353
    United States

    Site Not Available

  • Montgomery Cancer Center

    Mt. Sterling, Kentucky 40353
    United States

    Site Not Available

  • St Joseph Mercy Hospital

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • St Joseph Mercy Hospital

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Local Institution

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Local Institution

    Pascagoula, Mississippi 39581
    United States

    Site Not Available

  • University Of Kansas Cancer Center

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School Of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756-0001
    United States

    Site Not Available

  • Clinical Research Alliance, Inc.

    Lake Success, New York 11042
    United States

    Site Not Available

  • Durham Va Medical Center (111g)

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Carolina Biooncology Institute

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Novant Health Oncology Specialists

    Lexington, North Carolina 27295
    United States

    Site Not Available

  • Piedmont Hematology Oncology Associates, Pllc

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Site Not Available

  • Gabrail Cancer Center Research

    Dover, Ohio 44622
    United States

    Site Not Available

  • Oklahoma Oncology And Hematology, Pc Dba

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Kaiser Permanente Northwest Region

    Portland, Oregon 97227
    United States

    Site Not Available

  • Guthrie Medical Group, P.C.

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Wjb Dorn Va Medical Center

    Columbia, South Carolina 29209
    United States

    Site Not Available

  • Cancer Center Of The Carolinas

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Associated in Oncology and Hematology

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Cancer Center At Cookeville Regional Medical Center

    Cookeville, Tennessee 38501
    United States

    Site Not Available

  • Tennessee Cancer Specialists

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Thompson Oncology Group

    Knoxville, Tennessee 37916
    United States

    Site Not Available

  • Texas Oncology, PA - South Austin Cancer Center

    Austin, Texas 78745
    United States

    Site Not Available

  • Texas Oncology Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Blue Ridge Cancer Care

    Blacksburg, Virginia 24060
    United States

    Site Not Available

  • Blue Ridge Cancer Care

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • Local Institution

    Everett, Washington 98201
    United States

    Site Not Available

  • Wisconsin Institutes for Medical Research

    Madison, Wisconsin 53705
    United States

    Site Not Available

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