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RECRUITING
NCT06927986
PHASE3

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

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2025-03-30

Completion Date

2026-08-30

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China