Identificador persistente para citar o vincular este elemento: http://hdl.handle.net/10553/128991
Título: STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non–Small Cell Lung Cancer With No Actionable Gene Alterations
Autores/as: Rodríguez Abreu, Delvys 
Bosch-Barrera, Joaquim
Gray, Jhanelle E.
Ahn, Myung Ju
Johnson, Melissa
Yu, Xinwei
Mohammad, Saad
Chen, Xueying
Todd, Trever
Kim, Jongseok
Reck, Martin
Clasificación UNESCO: 32 Ciencias médicas
320713 Oncología
3209 Farmacología
Palabras clave: Clinical Trial
Immunotherapy
Nsclc
Pd-1
Tigit
Fecha de publicación: 2024
Publicación seriada: Clinical Lung Cancer 
Resumen: Introduction: Dual inhibition with a T-cell immunoreceptor with immunoglobulin and ITIM domains plus programmed death (ligand)-1 (PD[L]-1) inhibitors, with or without chemotherapy, is an emerging therapeutic strategy in metastatic non–small cell lung cancer (mNSCLC). The STAR-121 (NCT05502237) phase III, global, randomized, open-label study will investigate first-line domvanalimab (anti-TIGIT) and zimberelimab (anti–PD-1) plus chemotherapy versus pembrolizumab plus chemotherapy in mNSCLC with no actionable gene alterations. Participants and Methods: Approximately 720 participants (≥18 years old) with untreated mNSCLC and no EGFR and ALK mutations will be randomized into 3 groups (A, B, or C) in a 4:4:1 ratio and stratified by baseline PD-L1 expression (tumor cells <50% vs. ≥50%), histology (squamous vs. nonsquamous), and geographic region (East Asia vs. non-East Asia). Group A will receive domvanalimab 1200 mg plus zimberelimab 360 mg plus platinum-doublet chemotherapy (PT), group B will receive pembrolizumab 200 mg plus PT, and group C will receive zimberelimab 360 mg plus PT, every 3 weeks. Treatment will be administered until disease progression or intolerable toxicity. Dual primary endpoints are progression-free survival (by blinded independent central review [BICR]) and overall survival for group A versus B. Key secondary endpoints comprise overall response rate (by BICR), safety, and quality of life. Exploratory endpoints include efficacy and safety between groups A and C, pharmacokinetics, patient-reported outcomes, and biomarkers. Conclusion: Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.
URI: http://hdl.handle.net/10553/128991
ISSN: 1525-7304
DOI: 10.1016/j.cllc.2023.12.010
Fuente: Clinical Lung Cancer [ISSN 1525-7304], v. 25 (3), p. 274-279, (Mayo 2024).
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