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Drug tunlametinib will be administered as 12mg BID

tunlametinib

paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin

Zhimei Zhu, Master

Jun Guo, M.D.

Hongqi Tian, phD

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.

A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 2:1 ratio by Interactive Web Response System（IWRS）.

Experimental group: subjects received continuous administration of tunlametinib capsules every 28 days, and the study treatment was terminated until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigators, or when the study was terminated (whichever occurred earlier).

Control group: subjects received the combination chemotherapy (paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin, investigator's choice according to the conditions of the subjects) every 28 days until intolerable toxicity, disease progression, withdrawal of informed consent, death, or when the risk outweigh the benefit assessed by the investigator or when the study was terminated (whichever occurred earlier).

Efficacy was evaluated by independent radiology review committee and the investigator, respectively.

Within 30 days after the last administration of the study drug, the safety of the subjects will also be closely monitored and recorded. After safety visit or the last administration of the study drug (whichever occurs later), subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death, lost to follow-up, withdrawal of informed consent, or the end of this study (whichever occurs earlier).

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

defined as the time from first dose to the earliest documented disease progression or death due to any cause

defined as the time from the date of taking drugs to the date of death due to any cause

Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death

Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death

Shanghai Kechow Pharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma	NCT06008106	Melanoma	tunlametinib paclitaxel +car...	18 Years -	Shanghai Kechow Pharma, Inc.
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma	NCT06008106	Melanoma	tunlametinib paclitaxel +car...	18 Years -	Shanghai Kechow Pharma, Inc.

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