臨床研究等提出・公開システム

Date of registration	June. 02, 2026
Last modified on	June. 02, 2026
Trial ID	jRCT2011260014

Scientific Title	A Study to Compare the Combination of Navlimetostat (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
Public Title	Study of Navlimetostat Combination Therapy in First-line Metastatic NSCLC with MTAP Deletion (CA2400029)

Contact for Scientific Queries	Name	Zhang Jennifer
	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	Zhang Jennifer
	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		April. 17, 2026
Target sample size		590
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	- 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).
	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)		Four arms, BMS-986504 Specified dose on specified days
Primary Outcome(s)		Progression-free survival (PFS) by 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	Hokkaido University Hospital Institutional Review Board
Address	Kita 14-jo Nishi 5-chome, Kita-ku, Sapporo-shi, Hokkaido , Hokkaido
Telephone	+81-11-706-5680
E-Mail	rinsho@huhp.hokudai.ac.jp
Approval Status	Approval
Date of approval	Mar. 17, 2026

Plan to share IPD	Yes
Plan description	BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Secondary ID(s)	NCT07063745
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	U.S./Australia/U.K./France/Germany/Sweden/Poland/Italy/Spain/Romania/China