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Trial ID CA240-0029  |   NCT07063745

A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

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Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • 92
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
    1. Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
      1. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
        1. Participants must have at least 1 measurable lesion as per RECIST v1.1.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
            1. Participants must not have symptomatic brain metastases or spinal cord compression.
              1. Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
                1. Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
                  Additional Information *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Active Comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel

                    Study Arms

                    Active Comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel

                    Study Arms

                    Placebo Comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
                    • Other: Placebo

                    Study Arms

                    Placebo Comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
                    • Other: Placebo

                    Study Arms

                    Active Comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel

                    Study Arms

                    Placebo Comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy

                    ASSIGNED INTERVENTION
                    • Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
                    • Other: Placebo
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