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Trial ID CA266-0002  |   NCT07361510

A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 122
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

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Key Eligibility Criteria

Inclusion Criteria

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  • Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
    1. Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
      1. Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
        1. Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
          1. Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
              1. Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
                1. Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
                  1. Participants must not an active autoimmune disease.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      Study Arms

                      Experimental: Arm A: Pumitamig

                      ASSIGNED INTERVENTION
                      • Drug: Pumitamig

                      Study Arms

                      Active Comparator: Arm B: Pembrolizumab

                      ASSIGNED INTERVENTION
                      • Drug: Pembrolizumab
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