Clinical Trial

Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer

Recruiting Phase 2
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Summary
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)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-05-06; most recent amendment 2025-08-04.
Status change: Not Yet Recruiting → Recruiting 2025-08-04
Trial Details
NCT Number NCT06970353
Lead Sponsor Fudan University
Conditions Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation, Advanced PDTC or ATC With NRAS Mutation
Enrollment 40 participants
Start Date 2025-05-27
Primary Completion 2026-12-30 (estimated)
Study Completion 2031-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-07