drugset / Trial / NCT07633873
SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC（SYNSTAR 04）
RandomizedParallel-groupSingle-blindTreatment
Summary
This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.
Timeline
- Start
- 2026-06-02
- Primary completion
- 2027-09-30
- Completion
- 2029-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Subject | Enlonstobart | Monoclonal antibody | 360 mg | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Pemetrexed | Small molecule | — | — |
| Subject | SYS6010 | Monoclonal antibody | 4.5 mg/kg | Intravenous |
| Comparator | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |