臨床研究等提出・公開システム

Date of registration	Dec. 19, 2025
Last modified on	April. 23, 2026
Trial ID	jRCT2021250039

Scientific Title	A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies
Public Title	A Study of BMS-986504 in Participants with Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer with Homozygous MTAP Deletion (CA2400009)

Contact for Scientific Queries	Name	Hreiki Joseph
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Hreiki Joseph
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 26, 2025
Target sample size		3
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation. Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition). At least 1 measurable lesion as per RECIST v1.1. Documented radiographic disease progression on or after the most recent line of treatment. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Participant must be >= 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF. Capability to swallow tablets intact (without chewing or crushing).
	Exclusion Criteria	Active brain metastases or carcinomatous meningitis. History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications. Prior treatment with a PRMT5 or MAT2A inhibitor. Known severe hypersensitivity to study treatment and/or any of its excipients. Other protocol-defined inclusion/exclusion criteria apply.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Carcinoma, Non-Small-Cell Lung
Intervention(s)		Two arm, BMS-986504 Specified dose on specified days
Primary Outcome(s)		Number of participants who achieve Objective Response (OR) utilizing the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome(s)		Number of participants who achieve disease control (DC) as assessed by RECIST v1.1

Primary Sponsor	Bristol-Myers Squibb

Secondary Sponsor

Name of Certified Review Board	Sendai Kosei Hospital Institutional Review Board
Address	4-15 Hirose-cho, Aoba-ku, Sendai-shi, Miyagi
Telephone	+81-22-222-6181
E-Mail	chiken@kosei-hp.or.jp
Approval Status	Approval
Date of approval	Oct. 27, 2025

Plan to share IPD	No

Secondary ID(s)	NCT06855771
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	US/Australia/UK/France/Germany/Sweden/Poland/Italy/Spain/Romania/China

History of Changes

No	Publication date
3	April. 23, 2026	(this page)	Changes
2	Jan. 23, 2026	Detail	Changes
1	Dec. 19, 2025	Detail

List of change history