Clinical Trial

Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma

Recruiting Phase 3
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Summary
This is a multicenter, two-arm, open-label, randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigator's choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before. Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-08-15.
Status change: Not Yet Recruiting → Recruiting 2024-06-26
Trial Details
NCT Number NCT06008106
Lead Sponsor Shanghai Kechow Pharma, Inc.
Conditions Melanoma
Enrollment 165 participants
Start Date 2023-11-02
Primary Completion 2027-09-22 (estimated)
Study Completion 2027-09-22 (estimated)
Updated on ClinicalTrials.gov 2024-06-28