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Активно (без набиране) Фаза 3 NCT04746924

A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

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

Спонсор: BeiGene

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
Кой може да участва
Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status ≤ 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply
Места на провеждане 19
Argentina (1)
Centro Medical Austral
Buenos Aires
Австралия (1)
Concord Repatriation General Hospital
Concord , New South Wales
Бразилия (1)
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília
Китай (1)
Anhui Provincial Hospital
Hefei , Anhui
Франция (1)
Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
Bayonne
Georgia (1)
High Technology Hospital Medcenter Ltd
Batumi
Германия (1)
Universitaetsklinikum Aachen
Aachen
Италия (1)
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna
Япония (1)
Nagoya University Hospital
Nagoya , Aichi-ken
Нидерландия (1)
Meander Medisch Centrum
Amersfoort
Полша (1)
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok
Russia (1)
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk , Arkhangelskaya oblast
Южна Корея (1)
Chungbuk National University Hospital
Cheongju-si , Chungcheongbukdo
Испания (1)
Hospital Universitario Fundacion Alcorcon
Alcorcón
Taiwan (1)
Changhua Christian Hospital
Changhua
Тайланд (1)
Siriraj Hospital
Bangkok
Турция (1)
Acibadem Adana Hospital
Adana
Ukraine (1)
Medical Center of Limited Liability Company Mriya Med Service
Kryvyi Rih
САЩ (1)
Providence Medical Foundation St Jude Heritage Healthcare
Fullerton , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
08.06.2021
Крайна дата
31.03.2026
Регистрационен номер
NCT04746924
Източник
anzctr
Запитване за медицински туризъм

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