Clinical Trial

SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ

Study acronym: SYNSTAR03
Not Yet Recruiting Phase 3
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Summary
This is a randomized, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of SYS6010 versus docetaxel in participants with Locally Advanced or Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer who Have Failed Standard Therapy. The primary Objective is to evaluate the efficacy of SYS6010 versus docetaxel in participants with EGFR wild-type locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). Secondary Objectives includes safety, quality of life, immunogenicity, biomarkers, and efficacy correlations of SYS6010 compared to docetaxel in the same patient population.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-24.
Trial Details
NCT Number NCT07442565
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions Non-Small Cell Lung Cancer
Enrollment 506 participants
Start Date 2026-03-10
Primary Completion 2027-12-30 (estimated)
Study Completion 2031-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-04