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
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Ipilimumab; Pemetrexed; Cisplatin; Carboplatin
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Carboplatin; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 367.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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). In osimertinib treated subjects, T790 testing is not
             required.

          -  No evidence of exon 20 T790M mutation obtained at progression on prior first- or
             second-generation EGFR TKI therapy. For participants who were treated with
             osimertinib, T790M testing is not required.

          -  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).

          -  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

        Other protocol defined inclusion/exclusion criteria apply