Clinical Trial

A Study of EP0031 (Lunbotinib) in Patients With Advanced RET-altered Malignancies

Recruiting Phase 1/2
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Summary
The aim of this study is to assess the safety, side effects and effectiveness of EP0031 (Lunbotinib) in patients with advanced RET-altered non-small cell lung cancer (NSCLC) in monotherapy and in combination with standard of care (SOC) chemotherapy.
Protocol Amendment History 5 changes
critical Primary endpoint(s) modified 2026-07-02
minor Trial arms changed: 6 -> 2 2026-07-02
notable Trial sites expanded: 40 -> 52 locations 2026-07-02
notable Primary completion pushed: 2026-12 -> 2027-03 2026-07-02
minor Completion pushed: 2027-06 -> 2028-03 2026-07-02
Trial Details
NCT Number NCT05443126
Lead Sponsor Ellipses Pharma
Conditions NSCLC
Enrollment 265 participants
Start Date 2022-09-30
Primary Completion 2027-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-01