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A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

Trial Status: Closed to Accrual

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

Inclusion Criteria

  • Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the local health authority, including but not limited to erlotinib, gefitinib, afatinib, dacomitinib and osimertinib).
  • No evidence of exon 20 T790M mutation obtained at progression on prior first- or second-generation EGFR TKI therapy.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC). For participants who were treated with osimertinib, T790M testing is not required.
  • Participants are eligible if central nervous system (CNS) metastases are considered to be adequately controlled/treated before or during the screening period and participants are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, participants must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization). Participants with asymptomatic CNS metastasis are eligible.
  • Eastern Cooperative Group (ECOG) Performance Status 0-1
  • Life expectancy is at least 3 months

Exclusion Criteria

  • Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI should receive osimertinib first as the standard of care (SOC). These participants are only eligible if they fail osimertinib as 2L.
  • who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
  • Carcinomatous meningitis
  • Active, known or suspected autoimmune disease are excluded
  • ALK translocation
  • Known SCLC transformation
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Contact: Courtney Wells
Phone: 310-453-2063

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: APPROVED
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Justin F. Gainor
Phone: 617-632-2366

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED

North Carolina

Durham
Duke University Medical Center
Status: COMPLETED

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-722
  • Secondary IDs NCI-2017-00322, 2017-002672-38, s16-01857
  • Clinicaltrials.gov ID NCT02864251