臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 29, 2024
Last modified on	Oct. 29, 2024
Trial ID	jRCT2051240173

Scientific Title	A Phase 3, Randomized, open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 expression of 1% to 49%
Public Title	A Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy in Participants with Non-squamous Stage IV or Recurrent NSCLC and PD-L1 1% to 49% (CA224-1093)

Contact for Scientific Queries	Name	Qureshi Anila
	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	Qureshi Anila
	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		Oct. 29, 2024
Actual date of first enrollment
Target sample size		80
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 histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory -Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. -Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of <= 1 at screening. -Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.
	Exclusion Criteria	-Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations. -Participants must not have untreated central nervous system (CNS) metastases. -Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization. -Participants must not have an active autoimmune disease. -Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids. -Participants must not have a history of myocarditis, regardless of etiology. -Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		NSQ, NSCLC
Intervention(s)		Arm A;Nivolumab/Relatlimab, Carboplatin, Pemetrexed, Cisplatin Arm B;Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		OS
Secondary Outcome(s)		PFS, ORR, DoR, Aes, SAEs, IMAEs, NSCLC-SAQ total score

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hyogo Cancer Center Institutional Review Board
Address	13-70 Kitaouji-cho, Akashi, Hyogo, Hyogo, Hyogo
Telephone	+81-78-929-1151
E-Mail
Approval Status	Approval
Date of approval	Oct. 18, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06561386
Issuing Authority	CT.gov

Countries of Recruitment（Except Japan）	United States/China/Romania/Germany/Total 22 countries.