RecruitingPhase 3NCT06008106

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

Sponsor

Shanghai Kechow Pharma, Inc.

Enrollment

165 participants

Start Date

Nov 2, 2023

Study Type

INTERVENTIONAL

Conditions

Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new targeted drug called tunlametinib against standard chemotherapy for people with advanced or metastatic melanoma (skin cancer) that has a specific gene change called an NRAS mutation. **You may be eligible if...** - You are 18 or older - You have advanced (stage III or IV) melanoma confirmed by biopsy - Your tumor has tested positive for an NRAS mutation - Previous immunotherapy did not work or you could not tolerate it - Your heart is pumping normally (ejection fraction ≥50%) - You are in reasonably good health and able to carry out daily activities **You may NOT be eligible if...** - You have untreated or symptomatic brain metastases - You received chemotherapy or targeted therapy within the past 4 weeks - You had a heart attack, stroke, or serious heart condition in the past 6 months - You were previously treated with a MEK inhibitor - You have active HIV, hepatitis B or C, or syphilis - You have trouble swallowing capsules or absorbing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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