Phase 2 Study of Selpercatinib with Radioactive Iodine to Restore Treatment Response in RET Fusion-Positive Radioiodine-Refractory Thyroid Cancer

What this Trial Is About

Researchers are studying the effectiveness of selpercatinib combined with standard treatments I-131 and thyrotropin alfa rhTSH to restore radioactive iodine uptake in people with RET fusion-positive radioiodine-refractory thyroid cancer. This Phase II clinical trial aims to see if adding selpercatinib can help these patients respond better to I-131 treatment, as current treatment options are limited for this disease type. Participants will receive selpercatinib orally twice daily for an initial 4-week treatment period. In the fourth week, they will get a therapeutic dose of I-131 NaI. If radioiodine uptake returns, participants may be offered a second 4-week course of selpercatinib with I-131 treatment. Thyrotropin alfa injections will be given according to protocol during treatment. Treatment continues as long as the disease does not worsen and side effects are manageable. During the study, participants will undergo screening, evaluations, and follow-up visits for up to 2 years after enrollment. Researchers will monitor tumor response using imaging criteria, biochemical markers, and safety assessments. The primary outcome is the objective response rate at 6 months, with secondary outcomes including restoration of iodine uptake, progression-free survival, overall survival, and treatment-related side effects. Participants will be closely followed to assess the treatment impact and safety.

Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC