Study of Selpercatinib Followed by Radioactive Iodine Therapy in Children, Teens, and Young Adults With RET Fusion Differentiated Thyroid Cancer

What this Trial Is About

Papillary thyroid cancer PTC is the most common type of differentiated thyroid cancer DTC. After surgery, patients with advanced DTC usually receive radioactive iodine RAI therapy, but this treatment has limited success for lung metastases and carries risks like lung damage and secondary cancers. Researchers are studying a combination of selpercatinib followed by RAI therapy to evaluate its effects and safety in patients with RET fusion differentiated thyroid cancer. Participants will receive selpercatinib alone for six months at the FDA-approved dose, followed by radioactive iodine 131I therapy. Selpercatinib is continued for five days after RAI treatment, then participants enter a monitoring period without treatment. If the disease progresses during selpercatinib treatment, patients will stop selpercatinib and proceed directly to RAI therapy. During the study, participants will be monitored for lung and overall cancer response at 18 months, and survival without disease progression will be assessed over five years. Researchers will also measure changes in radioactive iodine uptake at six months and track any side effects or toxicities for up to 12 months. The total study duration extends up to seven years, including treatment and follow-up periods.

Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE)