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

NCT06927986 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2025-11-17

No results posted yet for this study

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)

Conditions

  • EGFR-mutated Locally Advanced or Metastatic NSCLC

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

Sponsors & Collaborators

  • CSPC Megalith Biopharmaceutical Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Shun Lu, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-30
Primary Completion
2026-07-30
Completion
2026-08-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06927986 on ClinicalTrials.gov