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Active (not recruiting) Phase 3 NCT04746924

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

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

Sponsor: BeiGene

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 19
Argentina (1)
Centro Medical Austral
Buenos Aires
Australia (1)
Concord Repatriation General Hospital
Concord , New South Wales
Brazil (1)
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília
China (1)
Anhui Provincial Hospital
Hefei , Anhui
France (1)
Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
Bayonne
Georgia (1)
High Technology Hospital Medcenter Ltd
Batumi
Germany (1)
Universitaetsklinikum Aachen
Aachen
Italy (1)
Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
Bologna
Japan (1)
Nagoya University Hospital
Nagoya , Aichi-ken
Netherlands (1)
Meander Medisch Centrum
Amersfoort
Poland (1)
Uniwersytecki Szpital Kliniczny W Bialymstoku
Bialystok
Russia (1)
Arkhangelsk Regional Clinical Oncological Dispensary
Arkhangelsk , Arkhangelskaya oblast
South Korea (1)
Chungbuk National University Hospital
Cheongju-si , Chungcheongbukdo
Spain (1)
Hospital Universitario Fundacion Alcorcon
Alcorcón
Taiwan (1)
Changhua Christian Hospital
Changhua
Thailand (1)
Siriraj Hospital
Bangkok
Turkey (1)
Acibadem Adana Hospital
Adana
Ukraine (1)
Medical Center of Limited Liability Company Mriya Med Service
Kryvyi Rih
United States (1)
Providence Medical Foundation St Jude Heritage Healthcare
Fullerton , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.06.2021
Completion date
31.03.2026
Registry ID
NCT04746924
Source
anzctr
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