Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • tunlametinib

    Drug

    12mg BID

  • paclitaxel +carboplatin, or temozolomide +cisplatin, or dacarbazine +cisplatin

    Drug

    according to investigators' suggestion

Treatment groups

165 Participants
are divided into 2 treatment groups
Group A: tunlametinibExperimental treatment 1 intervention
Group B: Assigned InterventionsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free Survival(PFS)

defined as the time from first dose to the earliest documented disease progression or death due to any cause

Time frame
up to 12 months

Secondary outcomes

1

Overall survival(OS)

defined as the time from the date of taking drugs to the date of death due to any cause

Time frame
up to 12 months
2

Duration of response(DOR)

Duration of response is defined as subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death

Time frame
up to 12 months
3

Disease control rate(DCR)

Proportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Kechow Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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