OncoMatch/Clinical Trials/NCT06970353
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
Is NCT06970353 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tunlametinib and Tunlametinib+PD-1 mAb for radioactive iodine-refractory, differentiated thyroid cancer with nras mutation.
Treatment: Tunlametinib · Tunlametinib+PD-1 mAb — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Biomarker criteria
Required: NRAS mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); ANC ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance rate >60 mL/min
Liver function
ALT, AST, ALP ≤ 2.5x ULN (≤ 5x ULN with liver metastasis, ALP ≤ 6x ULN with liver metastasis); total bilirubin ≤ 1.5x ULN; albumin ≥ 30 g/L
Cardiac function
LVEF ≥ 55%; ECG QTcF ≤ 480ms; CK ≤ 1 × ULN; troponin/hypersensitive troponin ≤ 1 × ULN
The main organ function and bone marrow function are normal. Blood routine: Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); Absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L; Liver function: ALT, AST, ALP ≤ 2.5x ULN (≤ 5x ULN with liver metastasis, ALP ≤ 6x ULN with liver metastasis); total bilirubin ≤ 1.5x ULN; albumin ≥ 30 g/L; Renal function: serum creatinine ≤ 1.5x ULN or creatinine clearance rate >60 mL/min; Cardiac function: LVEF ≥ 55%; ECG QTcF ≤ 480ms; CK ≤ 1 × ULN; troponin/hypersensitive troponin ≤ 1 × ULN; Coagulation function: INR ≤ 1.5x ULN; APTT ≤ 1.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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