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Набира участници Фаза 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%

Фаза 3 – широко изпитване преди одобрение
Заболявания: Non-small Cell Lung Cancer

Спонсор: Bristol-Myers Squibb

Налично на: БГ
Обобщение
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%
Кой може да участва
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.
Места на провеждане 27
Argentina (1)
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires , Buenos Aires
Karina Vera, Site 0379
Австралия (1)
Gosford Hospital
Gosford , New South Wales
Matthew Chan, Site 0058
Белгия (1)
Antwerp University Hospital
Edegem , Antwerpen
Reinier Wener, Site 0396
Бразилия (1)
Pronutrir
Fortaleza , Ceará
Herbert Tavares Palmeira, Site 0382
Chile (1)
Orlandi Oncologia
Santiago , Santiago Metropolitan
Francisco Orlandi, Site 0213
Китай (1)
Local Institution - 0182
Hefei , Anhui
NOT_YET_RECRUITING
Colombia (1)
Local Institution - 0415
Medellín , Antioquia
NOT_YET_RECRUITING
Дания (1)
Aarhus Universitetshospital, Skejby
Aarhus , Central Jutland
Pernille Elming, Site 0198
Франция (1)
CHRU de Brest
Brest , Finistère
Gilles Quere, Site 0462
Индия (1)
Manipal Hospitals
Bengaluru , Karnataka
Amit Rauthan, Site 0333
Ireland (1)
St. James's Hospital
Dublin
Sinead Cuffe, Site 0367
Италия (1)
Instituto Tumori Giovanni Paolo II
Bari , Apulia
Domenico Galetta, Site 0043
Япония (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
Нидерландия (1)
Local Institution - 0030
Harderwijk , Gelderland
WITHDRAWN
New Zealand (1)
Local Institution - 0407
Tauranga , Bay of Plenty
NOT_YET_RECRUITING
Полша (1)
Local Institution - 0255
Konin , Greater Poland Voivodeship
NOT_YET_RECRUITING
Румъния (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
Южна Корея (1)
Chungbuk National University Hospital
Cheongju-si , Chungcheongbuk-do [Chungbuk]
Ki Hyeong Lee, Site 0220
Испания (1)
CHUAC-Hospital Teresa Herrera
A Coruña , A Coruña [La Coruña]
Maria Garcia Campelo, Site 0270
Швейцария (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
Турция (1)
Local Institution - 0361
Adana
NOT_YET_RECRUITING
Великобритания (1)
Local Institution - 0441
Exeter , Devon
WITHDRAWN
САЩ (1)
Southern Arizona VA Health Care System
Tucson , Arizona
Thomas Hanzlik, Site 0368
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.10.2024
Крайна дата
04.08.2032
Регистрационен номер
NCT06561386
Източник
anzctr
Запитване за медицински туризъм

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