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

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.

Trial Details

NCT ID
NCT06008106
Phase
PHASE3
Sponsor
Shanghai Kechow Pharma, Inc.
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • tunlametinib
  • paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • ≥ 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;.

For full eligibility, visit ClinicalTrials.gov.

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