Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
This phase II trial evaluates Tunlametinib (MEK inhibitor) ± PD-1 in NRAS-mutant advanced thyroid cancer.
Key Objectives:
Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles
Study Design:
Single-arm, single-center 4 cohorts based on:
* Histology (differentiated vs. poorly/undifferentiated)
* Prior therapy status
Treatment:
* Cohorts 1-2: Tunlametinib monotherapy (12mg BID)
* Cohorts 3-4: Tunlametinib + PD-1 (commercially available)
Key Procedures:
Screening: NRAS testing + full staging (CT/MRI/PET) Monitoring: q3-week labs, q9-week imaging Follow-up: 30-day safety visit + q3-month survival tracking
Endpoints:
Primary: ORR Secondary: Safety (CTCAE), PFS, DoR
Unique Aspects:
First study targeting NRAS in thyroid cancer with MEK+PD-1 Includes rare aggressive subtypes (poorly/undifferentiated)
Gender: All
Ages: 18 Years - Any
Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation
Advanced PDTC or ATC With NRAS Mutation