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  • NCT02998528

Active, Not Recruiting

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) - CA209-816

Updated: 12 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: Nivolumab plus Ipilimumab
Biological: Nivolumab, Ipilimumab
Experimental: Nivolumab plus platinum doublet chemotherapy
Biological: Nivolumab Drug: Cisplatin, Gemcitabine, Pemetrexed, Carboplatin, Paclitaxel
Active Comparator: Platinum doublet chemotherapy
Drug: Cisplatin, Vinorelbine, Gemcitabine, Docetaxel, Pemetrexed, Carboplatin, Paclitaxel

Key Eligibility Criteria

Inclusion Criteria: - Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue - Lung function capacity capable of tolerating the proposed lung surgery - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Available tissue of primary lung tumor Exclusion Criteria: - Presence of locally advanced, inoperable or metastatic disease - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply

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