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Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer - Non Small Cell

Thank you

Trial Information

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



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

- Stage IV or recurrent NSCLC

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

- Brain Metastases

- Autoimmune diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival (defined as the time from the date of randomization until the date of death or the last known date the subject was alive)

Outcome Description:

Until 705 Death Events have occurred, Interim analysis at 528 events

Outcome Time Frame:

Approximately 48 months post study start

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA184-104

NCT ID:

NCT01285609

Start Date:

August 2011

Completion Date:

December 2016

Related Keywords:

  • Lung Cancer - Non Small Cell
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Sharp Memorial HospitalSan Diego, California  92123
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
WJB Dorn VA Medical CenterColumbia, South Carolina  29209
Local InstitutionFort Lauderdale, Florida  
Kentucky Cancer ClinicPikeville, Kentucky  41501
Piedmont Hematology Oncology Associates, PLLCWinston-Salem, North Carolina  
Kaiser Permanente NorthwestPortland, Oregon  97227
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Montgomery Cancer CenterMt. Sterling, Kentucky  40353
St. Francis Hospital & Health CentersBeech Grove, Indiana  46107
Guthrie Clinic Ltd.Sayre, Pennsylvania  18840
Quincy Medical GroupQuincy, Illinois  62301
Blue Ridge Cancer CareRoanoke, Virginia  24019
Texas Oncology Sammons Cancer CenterDallas, Texas  75246
Gabrail Cancer Center ResearchCanton, Ohio  44718
Orchard Healthcare Research Inc.Skokie, Illinois  60076
Lynn Cancer Institute Center For Hematology-OncologyBoca Raton, Florida  33486
Floyd Memorial Cancer Center of IndianaNew Albany, Indiana  47150
Kansas City Cancer Centers -SouthKansas City, Missouri  64131
Clinical Research Alliance, Inc.Lake Success, New York  11042
Durham Va Medical Center (111g)Durham, North Carolina  27705
Oklahoma Oncology And Hematology, Pc DbaTulsa, Oklahoma  74104
St Joseph Mercy HospitalAnn Arbor, Michigan  48106