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Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer

NCT05783323 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Differentiated Thyroid Cancer
  • Pediatric Cancer
  • Cancer
  • Cancer, Thyroid

Interventions

DRUG

Larotrectinib monotherapy

Patients will receive larotrectinib monotherapy for 6 months at the FDA-approved dose.

RADIATION

131I therapy

Patients will receive 131I therapy after 6 months of larotrectinib.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2026-10-01
Completion
2027-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05783323 on ClinicalTrials.gov