Clinical Trial

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

Study acronym: SYNSTAR-02
Not Yet Recruiting Phase 3
View on ClinicalTrials.gov →
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 680 participants, who will be randomized in a 1:1 ratio into the following groups: Test group: SYS6010 + osimertinib Control group: Investigator's choice of one treatment（Osimertinib or Osimertinib+ Chemotherapy）
Protocol Amendment History 1 change
notable Enrollment increased: 450 -> 680 participants 2026-05-14
Trial Details
NCT Number NCT07376382
Lead Sponsor CSPC Megalith Biopharmaceutical Co.,Ltd.
Conditions NSCLC
Enrollment 680 participants
Start Date 2026-06-01
Primary Completion 2026-12-12 (estimated)
Study Completion 2029-06-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-13