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  • NCT07063745

Not Yet Recruiting

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 - CA240-0029

Updated: 3 July, 2025   |   ClinicalTrials.gov

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Trial Details

  • Phase 2/Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 77

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy
Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
Active Comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy
Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
Placebo Comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy
Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel Other: Placebo
Placebo Comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy
Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel Other: Placebo
Active Comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy
Drug: BMS-986504, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel
Placebo Comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy
Drug: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel, Nab-paclitaxel Other: Placebo

Key Eligibility Criteria

Inclusion Criteria - 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. - Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss. - Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - Participants must have at least 1 measurable lesion as per RECIST v1.1. Exclusion Criteria - 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. - Participants must not have symptomatic brain metastases or spinal cord compression. - 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. - 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. - Other protocol-defined Inclusion/Exclusion criteria apply.

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466-DK-2200001