臨床研究等提出・公開システム

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 >= 1%

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression >= 1% (RELATIVITY1093)
(CA224-1093)

Qureshi Anila

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Qureshi Anila

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Recruiting

Oct. 29, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-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% 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.

-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 leptomeningeal metastases (carcinomatous meningitis).
-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.

Both

NSQ, NSCLC

Arm A;Nivolumab/Relatlimab, Carboplatin, Pemetrexed, Cisplatin
Arm B;Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin

Overall survival (OS) in randomized participants with PD-L1 1% to 49%

OS in randomized participants with PD-L1 >= 1%, PFS, ORR, DoR, AEs, SAEs, IMAEs, NSCLC-SAQ total score

+81-78-929-1151

Oct. 18, 2024

No

United States/China/Romania/Germany/Total 30 countries.