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