A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

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About the study

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
    2. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
    3. Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
    4. Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
    2. Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
    3. Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated 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 first treatment

    Other protocol inclusion/exclusion criteria may apply


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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition
    Non-Small Cell Lung Cancer
    Age (in years)
    18+
    Phase
    Phase 3
    Participants needed
    719
    Est. Completion Date
    Jan 19, 2026
    Treatment type
    Interventional

    Sponsor
    Bristol-Myers Squibb
    ClinicalTrials.gov identifier
    NCT03215706
    Study number
    CA2099LA

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