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Clinical Trials List

Protocol NumberCA2400029
NCT Number(ClinicalTrials.gov Identfier)NCT07063745
Active

2025-08-01 - 2032-03-02

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林正耀 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu Division of Thoracic Medicine
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Cheng Chang 無
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Objectives

Phase II Primary Objectives: • Evaluate the progression-free survival (PFS) of BMS-986504 + pembrolizumab + chemotherapy compared to placebo + pembrolizumab + chemotherapy in patients with treatment-naïve MTAP-deficient mNSCLC. Phase III Primary Objectives: • Compare the PFS of BMS-986504 + pembrolizumab + chemotherapy compared to placebo + pembrolizumab + chemotherapy in patients with treatment-naïve MTAP-deficient mNSCLC. • Compare the overall survival (OS) of BMS-986504 + pembrolizumab + chemotherapy compared to placebo + pembrolizumab + chemotherapy in patients with treatment-naïve MTAP-deficient mNSCLC.

Test Drug

Tablets

Active Ingredient

BMS-986504 (MRTX1719)

Dosage Form

110

Dosage

200 mg

Endpoints

Phase II Primary Assessment Measure:

• Progression-free survival (PFS) assessed by the trial administrator according to RECIST v1.1, defined as the time from randomization date to disease progression or death from any cause (whichever occurs first).

Phase III Primary Assessment Measure:
• Blinded Independent Central Review (BICR) PFS according to RECIST v1.1, defined as the time from randomization date to disease progression or death from any cause (whichever occurs first).
• Overall survival (OS) defined as the time from randomization date to death from any cause.

Inclution 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

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.

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    590 participants

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