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A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Patients With EGFR Mutation, T790M Negative NSCLC Who Have Failed 1L EGFR TKI Therapy - CA209-722

Updated: 24 September, 2018   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3


  • Gender(s)

  • 18+

    Age Range

  • 24


  • Recruiting

Treatment Options

Study Arms
Experimental: Nivolumab + Ipilimumab
Biological: Ipilimumab Biological: Nivolumab
Experimental: Nivolumab+Platinum doublet chemotherapy
Biological: Nivolumab Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed
Active Comparator: Platinum doublet chemotherapy
Drug: Pemetrexed Drug: Carboplatin Drug: Cisplatin

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Confirmed stage IV or recurrent EGFR Mutation (MT)+ NSCLC with disease progression after 1 prior EGFR TKI therapy - No evidence of exon 20 T790M mutation after progression on prior EGFR tyrosine kinase inhibitor(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) and exon 20 T790M testing Exclusion Criteria: - Subjects with symptomatic central nervous system (CNS) metastases - Subjects with carcinomatous meningitis - Subjects with an active, known or suspected autoimmune disease are excluded - Subjects with known SCLC transformation Other protocol defined inclusion/exclusion criteria could apply

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