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

NCT06008106 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2024-06-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

tunlametinib

12mg BID

DRUG

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

according to investigators' suggestion

Sponsors & Collaborators

  • Shanghai Kechow Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Hongqi Tian, phD · Shanghai Kechow Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2027-09-22
Completion
2027-09-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06008106 on ClinicalTrials.gov