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  • NCT02477826
This clinical trial is no longer recruiting patients.

Active, Not Recruiting

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) - CA209-227

Updated: 30 October, 2023   |   ClinicalTrials.gov

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Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Nivolumab
Drug: Nivolumab
Experimental: Arm B: Nivolumab + Ipilimumab
Drug: Nivolumab, Ipilimumab
Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy
Drug: Paclitaxel, Nivolumab, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed
Experimental: Arm D: Platinum doublet chemotherapy
Drug: Carboplatin, Cisplatin, Gemcitabine, Pemetrexed, Paclitaxel

Key Eligibility Criteria

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 Other protocol defined inclusion/exclusion criteria apply

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