A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04746924Tipo: INTERVENTIONALInicio: 8 de jun de 2021Fin estimado: 31 de mar de 2026

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.
No prior systemic treatment for metastatic NSCLC.
Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
Tumors with PD-L1 expressed in ≥ 50% tumor cells.
At least 1 measurable lesion as defined per RECIST v1.1.
ECOG Performance Status ≤ 1.

Criterios de exclusión

Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1.
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.
Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Active autoimmune diseases or history of autoimmune diseases that may relapse.

Intervenciones

drug

Tislelizumab

Tislelizumab is a monoclonal antibody formulated for intravenous injection.

drug

Ociperlimab

Ociperlimab is a monoclonal antibody formulated for intravenous injection.

drug

Pembrolizumab

Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

drug

Placebo

Placebo infusions will consist of a sterile, normal saline solution.

Ubicaciones

Centro Medical Austral

Buenos Aires, Argentina

Centro Para La Atencion Del Paciente Oncologico (Caipo)

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBeiGene

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase 3, Randomized, Double-Blind Study of Ociperlimab,... | EligiMed