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Trial ID CA052-1000  |   NCT07680764

A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 43
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.
    1. Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
      1. Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.
        1. Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
          1. Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

            Exclusion Criteria

            Exclusion Criteria Icon
            • Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.
              1. Participants must not have prior treatment with immuno-oncology therapies.
                1. Participants must not have untreated central nervous system (CNS) metastases.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Arm A

                    ASSIGNED INTERVENTION
                    • Drug: Pumitamig, Imzokitug

                    Study Arms

                    Experimental: Arm B

                    ASSIGNED INTERVENTION
                    • Drug: Pumitamig, Imzokitug

                    Study Arms

                    Experimental: Arm C

                    ASSIGNED INTERVENTION
                    • Drug: Pumitamig, Imzokitug

                    Study Arms

                    Experimental: Arm D

                    ASSIGNED INTERVENTION
                    • Drug: Pumitamig
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