drugset / Trial / NCT07376382
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 680 participants, who will be randomized in a 1:1 ratio into the following groups: Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）
Timeline
- Start
- 2026-06-01
- Primary completion
- 2026-12-12
- Completion
- 2029-06-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | — |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | — |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | — |
| Subject | SYS6010 | Monoclonal antibody | — | Intravenous |
| Background | Osimertinib | Small molecule | 80 mg | Oral |