Last updated 5 days ago
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%
1000 patients around the world
Available in Chile, Brazil, Argentina
Bristol-Myers Squibb
17Research sites
1000Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 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.Other protocol-defined Inclusion/Exclusion criteria apply.
Sites
Hospital Privado de la Comunidad
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Sanatorio Parque - Rosario
Recruiting
Hospital Privado de Córdoba
Recruiting
Instituto Médico Río Cuarto
Recruiting
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Recruiting
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Recruiting
StudyRELATIVITY1093
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06561386
