drugset / Trial / NCT06008106
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-11-02
- Primary completion
- 2027-09-22
- Completion
- 2027-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Comparator | Dacarbazine | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | Temozolomide | Small molecule | — | — |
| Subject | Tunlametinib | Small molecule | 12 mg | — |