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A Study of SYS6010 Plus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy in Non-small Cell Lung Cancer (NSCLC)
Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.
Summary
The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).
Official title: A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
570
Start Date
2026-06-25
Completion Date
2031-11-30
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
SYS6010
SYS6010
Enlonstobart
Enlonstobart
Tislelizumab
administered via Intravenous (IV) injection
Toripalimab ±+platinum-based doublet chemotherapy
Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;
Durvalumab
Durvalumab
Pembrolizumab
Pembrolizumab
Nivolumab
Nivolumab