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.
This is an open label, non-randomized study to evaluate the efficacy and safety of the combination of larotrectinib followed by 131I therapy for patients with NTRK fusion differentiated thyroid cancer. The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of larotrectinib given for 6-months followed by 131I therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.
Patients will receive 131I therapy after 6 months of larotrectinib.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGSt. Jude Children's Research Hospital
Memphis, Tennessee, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGSeattle Children's Hospital
Seattle, Washington, United States
RECRUITINGNumber of patients with complete pulmonary structural response
The primary endpoint is the complete pulmonary structural response rate to larotrectinib by modified Nies et al thyroid cancer response criteria.
Time frame: 18 months
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