Actively Recruiting
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Led by Shanghai Kechow Pharma, Inc. · Updated on 2024-06-28
165
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Unresectable stage III or metastatic stage IV melanoma confirmed by histology or cytology
- History of immunotherapy failure or intolerance
- Presence of NRAS mutation at baseline
- At least one evaluable target lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy longer than 3 months
- No major surgery or major trauma within 4 weeks before starting study drug (excluding baseline tumor biopsy)
- Left ventricular ejection fraction of 50% or higher within 7 days before dosing
- Key laboratory tests within 7 days before dosing meeting inclusion requirements
- Ability to understand and voluntarily sign the informed consent form
- Willingness and ability to complete study procedures and follow-up examinations
You will not qualify if you...
- Received chemotherapy, targeted therapy, or other study drug treatment within 4 weeks or 5 half-lives of the drug before first administration
- Received immunotherapy or biological therapy within 4 weeks before first administration
- Taken traditional Chinese medicines with anti-tumor activity within 2 weeks before first administration
- Toxic effects from previous anti-tumor treatment not fully recovered
- Current use of other anti-cancer drugs
- Symptomatic or untreated brain metastasis, meningeal metastasis, or spinal cord compression (except asymptomatic brain metastasis)
- History within 6 months of myocardial infarction, severe/unstable angina, coronary or peripheral artery bypass, symptomatic congestive heart failure, severe arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident, transient ischemic attack, diabetic ketoacidosis, deep vein thrombosis, or symptomatic pulmonary embolism
- QTcB interval 480 msec or higher during screening or history of congenital long QT syndrome
- History or current retinal diseases
- Previous or current neuromuscular diseases related to CK elevation
- Previous or current interstitial lung disease or pneumonitis
- Uncontrolled concomitant or infectious diseases
- Grade 3 bleeding symptoms within 4 weeks before study start
- Inability to swallow capsules or conditions interfering with drug absorption
- Use of strong CYP2C9 inducers or inhibitors at least 1 week before and during study
- History of malignancy within past 5 years
- Positive tests for HIV, syphilis, hepatitis C, or hepatitis B
- Prior treatment with MEK inhibitors
- Known hypersensitivity to study drugs or analogues
- History of bone marrow or organ transplantation
- Positive pregnancy test in premenopausal women
- Other severe clinical, psychiatric disorders, or lab abnormalities increasing risk or interfering with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lixia Gong, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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