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An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

Trial Status: Active

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and / or overall survival compared with chemotherapy in patients with advanced lung cancer.

Inclusion Criteria

  • Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
  • Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria

Exclusion Criteria

  • Subjects with untreated Central nervous system (CNS) metastases are excluded
  • Subjects with an active, known or suspected autoimmune disease are excluded
  • Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) indicating acute or chronic infection

California

San Diego
University of California San Diego
Status: IN_REVIEW

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: COMPLETED

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New York

Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Hongbin Chen
Phone: 716-845-3114
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: CLOSED_TO_ACCRUAL
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Matthew D. Hellmann
Phone: 646-888-4863

North Carolina

Durham
Duke University Medical Center
Status: COMPLETED
Contact: Neal E. Ready
Phone: 919-681-4768

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: COMPLETED
Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL
Thomas Jefferson University Hospital
Status: CLOSED_TO_ACCRUAL

South Carolina

Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Contact: David Eric Gerber
Phone: 214-648-1688
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Wallace Lovell Akerley
Phone: 801-587-4391

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-227
  • Secondary IDs NCI-2015-01262, 2014-003630-23, s16-02049
  • Clinicaltrials.gov ID NCT02477826