Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigator's Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy
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.
• ≥ 18 years of age.
• Patients with unresectable stage III or metastatic IV melanoma confirmed by histology or cytology.
• History of immunotherapy failure or could not tolerate immunotherapy
• NRAS mutation at baseline;.
• There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Eastern cooperative oncology group (ECOG) performance status of grade 0-1.
• Life expectancy \> 3 months.
• No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration.
• Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings.
⁃ Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria:
⁃ Able to understand and voluntarily sign the Informed Consent Form.
⁃ Patients must be willing and able to complete the study procedure and follow-up examination.