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NOT YET RECRUITING
NCT07672223
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

SYS6010

SYS6010

DRUG

Enlonstobart

Enlonstobart

DRUG

Tislelizumab

administered via Intravenous (IV) injection

DRUG

Toripalimab ±+platinum-based doublet chemotherapy

Cisplatin; Carboplatin; Pemetrexed; Paclitaxel;

DRUG

Durvalumab

Durvalumab

DRUG

Pembrolizumab

Pembrolizumab

DRUG

Nivolumab

Nivolumab