臨床研究等提出・公開システム

Date of registration	April. 27, 2026
Last modified on	April. 27, 2026
Trial ID	jRCT2051260034

Scientific Title	ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 >= 50%
Public Title	A Study of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 >=50% (CA2660002)

Contact for Scientific Queries	Name	Erdmann Coronado Cinthya
	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	Erdmann Coronado Cinthya
	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. 27, 2026
Actual date of first enrollment		April. 22, 2026
Target sample size		50
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease. - Participants must have a programmed death ligand-1 (PD-L1) expression >= 50%. - Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
	Exclusion Criteria	- Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated. - Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression. - Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage. - Participants must not an active autoimmune disease. - 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		Non-small Cell Lung Cancer (NSCLC)
Intervention(s)		Drug: Pumitamig Drug: Pembrolizumab
Primary Outcome(s)		- Progression-free survival (PFS) by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - Overall survival (OS)
Secondary Outcome(s)		- PFS by investigator according to RECIST v1.1 - OR by BICR according to RECIST v1.1 - DCR by BICR according to RECIST v1.1 - DOR by BICR according to RECIST v1.1 - TTR by BICR according to RECIST v1.1 - Time to definitive deterioration (TTDD) based on NSCLC-SAQ defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score

Primary Sponsor	Bristol-Myers Squibb

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Hyogo Medical University Hospital IRB
Address	1-1 Mukogawacho, Nishinomiya, Hyogo
Telephone	+81-798-45-6094
E-Mail	chiken02@hyo-med.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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Secondary ID(s)	NCT07361510

Countries of Recruitment（Except Japan）	United States/Argentina/Australia/Austria/Belgium/Brazil/Bulgaria/Canada/Chile/China/Colombia/Czech Republic/Finland/France/Germany/Hungary/India/Italy/Malaysia/Mexico/Netherlands/Norway/Peru/Poland/Portugal/Romania/Singapore/South Korea/Spain/Sweden