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Trial ID CA209-227  |   NCT02477826

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)

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A: Nivolumab

ASSIGNED INTERVENTION
  • Drug: Nivolumab

Study Arms

Experimental: Arm B: Nivolumab + Ipilimumab

ASSIGNED INTERVENTION
  • Drug: Nivolumab, Ipilimumab

Study Arms

Experimental: Arm C: Nivolumab + Platinum doublet chemotherapy

ASSIGNED INTERVENTION
  • Drug: Pemetrexed, Gemcitabine, Cisplatin, Carboplatin, Nivolumab, Paclitaxel

Study Arms

Experimental: Arm D: Platinum doublet chemotherapy

ASSIGNED INTERVENTION
  • Drug: Cisplatin, Carboplatin, Paclitaxel, Pemetrexed, Gemcitabine