drugset / Trial / NCT07442565

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

NCT07442565

Phase 3 Not yet recruiting 506 enrolled CSPC Megalith Biopharmaceutical Co.,Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-03-10
Primary completion
2027-12-30
Completion
2031-05-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject SYS6010 Monoclonal antibody 4.5 mg/kg Intravenous