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NCT06008106Not yet recruiting

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

Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy
Shanghai Kechow Pharma, Inc.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Melanoma
Drug/Device/Intervention
tunlametinib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Kechow Pharma, Inc.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 3
Start date
Sep 22, 2023
End date
Sep 22, 2027
Enrollment
165 participants
Primary outcome

Progression-free Survival(PFS)

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.

ICD-10 classifications
Malignant melanoma of skinMelanoma in situ, unspecifiedMelanoma in situMelanoma and other malignant neoplasms of skinMalignant neoplasm: Malignant melanoma of skin, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06008106
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06008106 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shanghai Kechow Pharma, Inc. and is currently Not yet recruiting. The study focuses on Melanoma. Target enrollment is 165 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.