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Clinical Trials List

Protocol NumberCA2400029
Active

2025-08-01 - 2032-03-02

Phase II

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

    2026/03/01

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
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of Hematology & Oncology
National Taiwan 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

Condition/Disease

Non-small Cell Lung Cancer

Objectives

To evaluate PFS of BMS-986504 + pembrolizumab + chemotherapy vs placebo + pembrolizumab + chemotherapy in previously untreated participants with mNSCLC with homozygous MTAP deletion

Test Drug

tablet

Active Ingredient

BMS-986504 (MRTX1719)

Dosage Form

110

Dosage

200 mg

Endpoints

PFS by RECIST v1.1 per investigator
assessment, defined as the time between
the randomization date and the date of
disease progression or death from any
cause (whichever occurs first)

Inclution Criteria

 Metastatic (Stage IV or recurrent) NSCLC (as defined by the American Joint
Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy
for metastatic disease.
 Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion or
MTAP loss detected in tumor tissue using a Sponsor-provided central test or a
Sponsor pre-approved local test.
 Any PD-L1 expression (0 to 100%) as determined by the Sponsor pre-approved
local PD-L1 IHC assays (VENTANA PD-L1 [SP263] assay, Agilent PD-L1 IHC
22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx), from tissue collected within
6 months prior to signing the pre-screening informed consent, performed in
accordance with the intended use of the assays. If, despite best efforts, a quantifiable
result is not possible, non-evaluable or non-quantifiable results may be acceptable
upon Medical Monitor (or designee) approval for a maximum of 10% of total
participants. Testing must comply with local diagnostic regulations, and
documentation of which PD-L1 test used must be provided.
 At least 1 measurable lesion as per RECIST v1.1.

Exclusion Criteria

 Nonsquamous participants with documented targetable oncogenic mutation or
AGAs for which there is a SoC available as 1L therapy (ie, EGFR, ALK, or ROS1)
 Symptomatic brain metastases or spinal cord compression.
 Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or
biological therapy) for mNSCLC.
Note: One cycle of SoC treatment prior to randomization will be allowed for
participants who require immediate treatment if clinically indicated.

The Estimated Number of Participants

  • Taiwan

    11 participants

  • Global

    590 participants

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