OncoMatch/Clinical Trials/NCT06458036
Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)
Is NCT06458036 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Selpercatinib Monotherapy for differentiated thyroid cancer.
Treatment: Selpercatinib Monotherapy — Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Biomarker criteria
Required: RET activating fusion
Identification of an activating RET gene alteration (fusion or mutation). The RET alteration result should ... denote the presence of a RET alteration without known kinase domain resistance mutation
Required: RET activating mutation
Identification of an activating RET gene alteration (fusion or mutation). The RET alteration result should ... denote the presence of a RET alteration without known kinase domain resistance mutation
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: systemic therapy
Exception: prior 131I is allowed
No prior systemic therapy for thyroid cancer, including RET inhibitors. Note: prior 131I is allowed.
Lab requirements
Blood counts
ANC ≥1500/µL; Platelet count ≥ 100,000/µL (transfusion independent); Hemoglobin ≥ 9.0 g/dL at baseline (may receive RBC transfusions)
Kidney function
Creatinine clearance or GFR ≥ 70 mL/min/1.73 m2 or a maximum serum creatinine based on age/gender
Liver function
Bilirubin ≤ 1.5 x ULN for age (except Gilbert syndrome <3.0x ULN); ALT <2.5x ULN OR <5x ULN if liver has tumor involvement; Serum albumin ≥ 2 g/dL
Adequate Organ Function: Bone Marrow Function: ANC ≥1500/µL; Platelet count ≥ 100,000/µL (transfusion independent); Hemoglobin ≥ 9.0 g/dL at baseline (may receive Red Blood Cell transfusions). Adequate Renal Function: Creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) ≥ 70 mL/min/1.73 m2 or a maximum serum creatinine based on age/gender. Adequate Liver Function: Bilirubin ≤ 1.5 x ULN for age. Except participants with a documented history of Gilbert syndrome who must have a total bilirubin level of <3.0X ULN. ALT <2.5X ULN OR <5x ULN if the liver has tumor involvement. For the purpose of this study, the ULN for ALT is 45 U/L. Serum albumin ≥ 2 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
- St. Jude Children's Research Hospital · Memphis, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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