OncoMatch/Clinical Trials/NCT06008106
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Is NCT06008106 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including tunlametinib and paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin for melanoma.
Treatment: tunlametinib · paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Melanoma
Biomarker criteria
Required: NRAS mutation
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immunotherapy
History of immunotherapy failure or could not tolerate immunotherapy
Cannot have received: chemotherapy
Exception: within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
received chemotherapy, targeted therapy or other study drug treatment within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
Cannot have received: targeted therapy
Exception: within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
received chemotherapy, targeted therapy or other study drug treatment within 4 weeks before the first administration or within 5 half lives of the drug (whichever is longer)
Cannot have received: immunotherapy
Exception: within 4 weeks before the first administration
received immunotherapy and biological therapy within 4 weeks before the first administration
Cannot have received: biological therapy
Exception: within 4 weeks before the first administration
received immunotherapy and biological therapy within 4 weeks before the first administration
Cannot have received: traditional Chinese medicines with anti-tumor activities
Exception: within 2 weeks before the first administration
received traditional Chinese medicines with anti-tumor activities approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration
Cannot have received: MEK inhibitor
Patients who have been previously treated with MEK inhibitors
Lab requirements
Blood counts
Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria
Kidney function
Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria
Liver function
Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings; ECG Corrected Q-T interval formula (QTcB) < 480 msec during screening
Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings. ECG Corrected Q-T interval formula (QTcB) ≥ 480 msec (adjusted by Bazett's formula) during screening, or a history of congenital long QT syndrome. Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06008106 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, immunotherapy disqualifies patients from enrollment.
Does this trial require NRAS?
Yes, NRAS mutation is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages