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NOT YET RECRUITING
NCT07633873
PHASE3

SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC(SYNSTAR 04)

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

Summary

This study was an open-label, multi-center, randomized phase III study to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart versus Immunotherapy+ Platinum-based chemotherapy as First-Line treatment for patients with PD-L1-Positive locally advanced or metastatic NSCLC.

Official title: An Open-label, Multicenter Randomized Phase III Study of SYS6010 Combined With Enlonstobart Versus Immunotherapy+ Platinum-based Chemotherapy as First-Line Treatment for Patients With PD-L1-Positive Locally Advanced or Metastatic NSCLC

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-06-02

Completion Date

2029-05-30

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

SYS6010 injection

SYS6010 is Lyophilized powder for injection as an EGFR-ADC. SYS6010 will be administered via intravenous infusion, Q3W, with 21 days as one treatment cycle, at a dose of 4.5 mg/kg.

DRUG

Enlonstobart injection

Enlonstobart is arecombinant human anti-PD-1 monoclonal antibody injection,and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 360 mg.

DRUG

Tislelizumab injection

Tislelizumab is a marketed recombinant human anti-PD-1 monoclonal antibody injection, and will be administered by intravenous infusion, Q3W, with 21 days as one treatment cycle at a dosage of 200 mg.

DRUG

Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin

Paclitaxel+Carboplatin or Pemetrexed + Cisplatin/Carboplatin are widely accepted and common chemotherapy medication. For squamous NSCLC, Paclitaxel+Carboplatin were recommended to be administrated on a 21-day cycle. For nonsquamous NSCLC, Pemetrexed + Cisplatin or Carboplatin were recommended to be administrated on a 21-day cycle.