RecruitingPhase 3NCT06927986

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


Sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Enrollment

380 participants

Start Date

Mar 30, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a new drug called SYS6010 works better than standard platinum-based chemotherapy for people with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called EGFR. Participants must have already tried and not responded to targeted EGFR therapies. **You may be eligible if...** - You are 18 to 75 years old - You have locally advanced or metastatic NSCLC with an EGFR mutation - Your previous EGFR-targeted therapy has stopped working - You have at least one measurable tumor on imaging - You are in reasonably good health (able to carry out daily activities) - Your liver, kidney, and blood counts meet required levels **You may NOT be eligible if...** - You have small cell lung cancer, squamous cell carcinoma, or certain other lung cancer subtypes - You have active or untreated brain/spinal cord metastases - You have had a serious heart attack, stroke, or heart failure recently - You have active lung disease (interstitial lung disease or pneumonitis) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSYS6010

SYS6010,Q3W

DRUGPemetrexed

Pemetrexed injection 500 mg/m\^2 administered via intravenous infusion,Q3W

DRUGCisplatin

Cisplatin 75 mg/m\^2 administered via intravenous infusion,Q3W

DRUGCarboplatin

Carboplatin (AUC=5, Calvert formula) administered via intravenous infusion,Q3W


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT06927986