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Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma - Trial NCT06008106

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.

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NCT06008106
Phase 3
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06008106
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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

Study Focus

Melanoma

tunlametinib

Interventional

drug

Sponsor & Location

Shanghai Kechow Pharma, Inc.

Beijing, China

Timeline & Enrollment

Phase 3

Sep 22, 2023

Sep 22, 2027

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 skin
Melanoma in situ, unspecified
Melanoma in situ
Melanoma and other malignant neoplasms of skin
Malignant neoplasm: Malignant melanoma of skin, unspecified

Data Source

ClinicalTrials.gov

NCT06008106

Non-Device Trial