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OncoMatch/Clinical Trials/NCT06079333

NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)

Is NCT06079333 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies dabrafenib/trametinib for anaplastic thyroid cancer.

Phase 2RecruitingLeiden University Medical CenterNCT06079333Data as of May 2026

Treatment: dabrafenib/trametinibAnaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans. Most patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and/or chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF/MEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.

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Extracted eligibility criteria

Cancer type

Thyroid Cancer

Biomarker criteria

Required: BRAF v600e/k

Performance status

WHO 0–1

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anticancer systemic treatment

No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies)

Cannot have received: radiation therapy

No prior radiotherapy to site of interest

Lab requirements

Blood counts

WBC ≥ 2.0x10^9/L, Neutrophils ≥ 1.0x10^9/L, Platelets ≥ 100 x10^9/L, Hemoglobin ≥ 6.5 mmol/L

Kidney function

Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate > 50 mL/min/1.73m2

Liver function

AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN

Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate > 50 mL/min/1.73m2.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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