Status:
RECRUITING
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Lead Sponsor:
Shanghai Kechow Pharma, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Detailed Description
A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 2:1 ratio by Interactive Web Response System（IWRS）. Experimental group: subjects received cont...
Eligibility Criteria
Inclusion
- ≥ 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;.
- There is at least one lesion that can be evaluated as target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Eastern cooperative oncology group (ECOG) performance status of grade 0-1.
- Life expectancy \> 3 months.
- No major surgery (excluding baseline tumor biopsy) or major trauma occurred at least 4weeks prior to investigational drug administration.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 7 days before dosing according to echocardiographic findings.
- Key laboratory tests must be conducted within 7 days before dosing and meet the inclusion criteria:
- Able to understand and voluntarily sign the Informed Consent Form.
- Patients must be willing and able to complete the study procedure and follow-up examination.
Exclusion
Key Trial Info
Start Date :
November 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 22 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06008106
Start Date
November 2 2023
End Date
September 22 2027
Last Update
June 28 2024
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142