NCT07376382

A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC

A Randomized, Open-label, Multicenter, Phase III Clinical Trial to Evaluate the Safety and Efficacy of SYS6010 in Combination With Osimertinib in Patients With EGFR-mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, open-label, multicenter Phase III clinical trial evaluating patients with EGFR-mutant locally advanced or metastatic NSCLC. The Phase III study is planned to enroll approximately 450 participants, who will be randomized in a 1:1 ratio into the following groups: Experimental group: SYS6010 + Osimertinib Control group: Osimertinib

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	SYS6010	SYS6010，intravenous injection
DRUG	Osimertinib	Osimertinib 80mg P.O. QD

Timeline

• Start date: 2026-03-03
• Primary completion: 2026-12-12
• Completion: 2029-06-06
• First posted: 2026-01-29
• Last updated: 2026-02-02