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Recruiting Phase 3 NCT06561386

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%

Phase 3 – large-scale trial before approval
Conditions: Non-small Cell Lung Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
Who can participate
Inclusion Criteria * Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. * 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 a life expectancy of at least 3 months at the time of randomization. Exclusion Criteria * Participants must not be pregnant and/or breastfeeding. * Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. * Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. * 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. * 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 to assist with management. * Participants must not have a history of myocarditis. * 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.
Locations 27
Argentina (1)
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires , Buenos Aires
Karina Vera, Site 0379
Australia (1)
Gosford Hospital
Gosford , New South Wales
Matthew Chan, Site 0058
Belgium (1)
Antwerp University Hospital
Edegem , Antwerpen
Reinier Wener, Site 0396
Brazil (1)
Pronutrir
Fortaleza , Ceará
Herbert Tavares Palmeira, Site 0382
Chile (1)
Orlandi Oncologia
Santiago , Santiago Metropolitan
Francisco Orlandi, Site 0213
China (1)
Local Institution - 0182
Hefei , Anhui
NOT_YET_RECRUITING
Colombia (1)
Local Institution - 0415
Medellín , Antioquia
NOT_YET_RECRUITING
Denmark (1)
Aarhus Universitetshospital, Skejby
Aarhus , Central Jutland
Pernille Elming, Site 0198
France (1)
CHRU de Brest
Brest , Finistère
Gilles Quere, Site 0462
India (1)
Manipal Hospitals
Bengaluru , Karnataka
Amit Rauthan, Site 0333
Ireland (1)
St. James's Hospital
Dublin
Sinead Cuffe, Site 0367
Italy (1)
Instituto Tumori Giovanni Paolo II
Bari , Apulia
Domenico Galetta, Site 0043
Japan (1)
National Cancer Center Hospital East
Kashiwa , Chiba
Yu Tanaka, Site 0312
Mexico (1)
Cancer Treamtent Clinic and Clinical Trials Sa de Cv
Guadalajara , Jalisco
Juan Vazquez Limon, Site 0170
Netherlands (1)
Local Institution - 0030
Harderwijk , Gelderland
WITHDRAWN
New Zealand (1)
Local Institution - 0407
Tauranga , Bay of Plenty
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0255
Konin , Greater Poland Voivodeship
NOT_YET_RECRUITING
Romania (1)
SC Memorial Healthcare International SRL
Bucharest , Bucharest
Ingrid Iordan, Site 0296
Saudi Arabia (1)
Local Institution - 0440
Dammam , Eastern Province
NOT_YET_RECRUITING
South Africa (1)
Local Institution - 0431
Soweto , Gauteng
NOT_YET_RECRUITING
South Korea (1)
Chungbuk National University Hospital
Cheongju-si , Chungcheongbuk-do [Chungbuk]
Ki Hyeong Lee, Site 0220
Spain (1)
CHUAC-Hospital Teresa Herrera
A Coruña , A Coruña [La Coruña]
Maria Garcia Campelo, Site 0270
Switzerland (1)
Local Institution - 0291
Lausanne , Canton of Vaud
NOT_YET_RECRUITING
Taiwan (1)
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist , Kaohsiung
Chin-Chou Wang, Site 0445
Turkey (1)
Local Institution - 0361
Adana
NOT_YET_RECRUITING
United Kingdom (1)
Local Institution - 0441
Exeter , Devon
WITHDRAWN
United States (1)
Southern Arizona VA Health Care System
Tucson , Arizona
Thomas Hanzlik, Site 0368
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.10.2024
Completion date
04.08.2032
Registry ID
NCT06561386
Source
anzctr
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