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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-73L  |   NCT04026412

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

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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 primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
    1. Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
      1. Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
          1. Active infection requiring systemic therapy within 14 days prior to randomization
            1. History of organ or tissue transplant that requires systemic use of immune suppressive agents
              1. Prior thoracic radiotherapy Other protocol-defined inclusion/exclusion criteria apply
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Arm A: nivolumab + CCRT + ipilimumab

                ASSIGNED INTERVENTION
                • Biological: nivolumab, ipilimumab

                Study Arms

                Experimental: Arm B: nivolumab + CCRT

                ASSIGNED INTERVENTION
                • Biological: nivolumab

                Study Arms

                Experimental: Arm C: CCRT + durvalumab

                ASSIGNED INTERVENTION
                • Biological: durvalumab

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