Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer (NCT05783323)

🧪 Interventions in This Study

• Larotrectinib monotherapy (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age ≥ 1 year
2. Histologic diagnosis of a differentiated thyroid cancer, s/p thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator
3. Anatomically evaluable disease on chest CT meeting one of the following criteria (obtained within 90 days of enrollment): A. multiple (\> 10) noncalcified solid pulmonary nodules visible on CT and/or B. enlarging, discrete pulmonary nodules visible on CT of any number consistent with metastatic disease
4. Identification of an neurotrophic tyrosine receptor kinase (NTRK) (NTRK1, NTRK2, or NTRK3) gene fusion in a CLIA/CAP accredited laboratory without known kinase domain resistance mutation
5. Lansky/Karnofsky performance status ≥ 50%
6. Adequate Organ Function A. Bone Marrow Function:
7. Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3
8. Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
9. Hemoglobin ≥ to 8.0 g/dL at baseline (may receive red blood cell (RBC) transfusions). B. 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 as follows: Age Maximum Serum Creatinine (mg/dL) Male Female 1 to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1 1 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.5 ≥ 16 years 1.7 1.7 C. Adequate Liver Function
10. Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age.
11. Serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
12. Serum albumin ≥ 2 g/dL

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

• University of California, San Francisco — San Francisco, California
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• St. Jude Children's Research Hospital — Memphis, Tennessee
• MD Anderson Cancer Center — Houston, Texas
• Seattle Children's Hospital — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (267) 426-9343

Email: donnellymt@chop.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Differentiated Thyroid Cancer

• Selpercatinib Pre-RAI in Patients With RET Fusion Thyroid Cancer (RAISE) — San Francisco, California
• A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy — Newport Beach, California

Explore by condition: All Differentiated Thyroid Cancer clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.