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Larotrectinib and 131I Therapy for Differentiated Thyroid Cancer with NTRK Fusion

This study is testing if a combination of two treatments, larotrectinib and radioactive iodine (131I therapy), can help patients with differentiated thyroid cancer, especially those with an NTRK gene change. Larotrectinib is given for six months, followed by 131I therapy. The study is looking for people aged 1 year to 99 years who have differentiated thyroid cancer that has spread, and whose cancer has an NTRK fusion. The main goal is to see how many patients have a complete structural response in their lungs after 18 months. The current status of this study is unclear, and it plans to enroll 13 participants.

Study design
This is an open-label study, meaning both you and your doctors will know which treatments you are receiving. It is not randomized, and it plans to enroll 13 participants.
What's involved
You would receive larotrectinib for six months, followed by 131I therapy. The study will measure your lung response at 18 months.
Compensation
Not stated in the trial record.
Follow-up
The study will measure your lung response at 18 months after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05783323

Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

Recruiting
PHASE2Ages 2–99InterventionalTreatment
Children's Hospital of Philadelphia
~13 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:Larotrectinib monotherapy131I therapy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with complete pulmonary structural response
Measured over 18 months

Conditions

Differentiated Thyroid Cancer
Pediatric Cancer
Cancer
Cancer, Thyroid

Explore related trials

Differentiated Thyroid Gland CarcinomaNTRK Family Gene

Where it's being run

5 sites across 5 states
California1
Pennsylvania1
Tennessee1
Texas1
Washington1

Study leadership

  • Theodore Laetsch, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Meghan Donnelly
[email protected]
267-426-9343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3
Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Hemoglobin ≥ to 8.0 g/dL at baseline (may receive red blood cell (RBC) transfusions).
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age.
Serum glutamic-pyruvic transaminase (SGPT) (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
Serum albumin ≥ 2 g/dL 7. Female patients of reproductive potential must agree to use a highly effective contraceptive method for the duration of study therapy and for at least one month after the final dose of larotrectinib. Males of reproductive potential with a non-pregnant female partner of child-bearing potential must use a highly effective contraception for the duration of the study and for at least one month after the final dose of larotrectinib.

What this trial measures

  • Number of patients with complete pulmonary structural response18 months

    The primary endpoint is the complete pulmonary structural response rate to larotrectinib by modified Nies et al thyroid cancer response criteria.