NCT06927986

Phase III Trial of SYS6010 Versus Platinum-based Chemotherapy for EGFR-mutated NSCLC（SYNSTAR01）

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a randomized, open-label, multi-center, phase III clinical study, aiming to evaluate the efficacy and safety of SYS6010 versus platinum-based chemotherapy in participants with EGFR-mutated locally advanced or metastatic NSCLC who have failed EGFR TKI therapy.

Conditions

• EGFR-mutated Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	SYS6010	SYS6010,Q3W
DRUG	Pemetrexed	Pemetrexed injection 500 mg/m\^2 administered via intravenous infusion，Q3W
DRUG	Cisplatin	Cisplatin 75 mg/m\^2 administered via intravenous infusion，Q3W
DRUG	Carboplatin	Carboplatin (AUC=5, Calvert formula) administered via intravenous infusion，Q3W

Timeline

• Start date: 2025-03-30
• Primary completion: 2026-07-30
• Completion: 2026-08-30
• First posted: 2025-04-15
• Last updated: 2025-11-17

Locations

1 site across 1 country: China