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Trial ID CA266-0001  |   NCT07361497

A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 125
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have a histologically
    1. or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.
      1. Participants must have received at least 2 cycles of platinum-based concurrent chemotherapy (a total dose of radiation of at least 54 Gy).
        1. Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
          1. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
              1. Participants must not have an active autoimmune disease.
                1. Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, 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 have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
                    1. Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Arm A

                        ASSIGNED INTERVENTION
                        • Drug: Pumitamig

                        Study Arms

                        Active Comparator: Arm B

                        ASSIGNED INTERVENTION
                        • Drug: Durvalumab
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