Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
ConditionMelanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Kechow Pharma, Inc.
About this trial
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 criteria
Qualifiers
≥ 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;.
Disqualifiers
Having the following treatment before receiving the study drug: ① 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); ② received immunotherapy and biological therapy within 4 weeks before the first administration; ③ received traditional Chinese medicines with anti-tumor activities approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration.;
The toxic reactions of previous anti-tumor treatment have not been recovered;
Current use of other anti-cancer drugs.
Subjects with symptomatic or untreated brain metastasis, meningeal metastasis or spinal cord compression except for subjects with asymptomatic brain metastasis;
Trial design
Treatments tested in this trial
- tunlametinib
- paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin
Treatment groups
165 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov