Clinical Trial: NCT06927986
Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）
Status:
RECRUITINGPhase:
Phase 3| Lead Sponsor: | CSPC Megalith Biopharmaceutical Co.,Ltd. |
| Information Provided By: | CSPC Megalith Biopharmaceutical Co.,Ltd. |
| Last Update Posted: | 2026-07-01 |
Study Overview
Brief Summary
To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Official Title
A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment
Conditions
EGFR-mutated Locally Advanced or Metastatic NSCLC
Intervention / Treatment
- Drug: SYS6010
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Other Study ID Numbers
- SYS6010-011
Start Date (Actual)
2025-03-30
Primary Completion Date (Estimated)
2026-07-30
Study Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
380
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | CSPC Megalith Biopharmaceutical Co.,Ltd. |
| Information Provided By: | CSPC Megalith Biopharmaceutical Co.,Ltd. |
| Last Update Posted: | 2026-07-01 |
Study Overview
Brief Summary
To evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
Official Title
A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment
Conditions
EGFR-mutated Locally Advanced or Metastatic NSCLC
Intervention / Treatment
- Drug: SYS6010
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin
Other Study ID Numbers
- SYS6010-011
Start Date (Actual)
2025-03-30
Primary Completion Date (Estimated)
2026-07-30
Study Completion Date (Estimated)
2026-08-30
Enrollment (Estimated)
380
Study Type
Interventional
Phase
Phase 3