Actively Recruiting
Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
Led by Children's Hospital of Philadelphia · Updated on 2025-11-14
13
Participants Needed
5
Research Sites
189 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 year or older
- Histologic diagnosis of differentiated thyroid cancer after thyroidectomy and adequate local treatment for neck metastatic disease
- Multiple (>10) noncalcified solid lung nodules or enlarging discrete lung nodules visible on chest CT within 90 days of enrollment
- Identification of NTRK gene fusion (NTRK1, NTRK2, or NTRK3) without kinase domain resistance mutation
- Lansky/Karnofsky performance status of 50% or higher
- Adequate bone marrow function: ANC ≥ 1000/mm3, platelet count ≥ 100,000/mm3 without recent transfusions, hemoglobin ≥ 8.0 g/dL (transfusions allowed)
- Adequate kidney function: Creatinine clearance or GFR ≥ 70 mL/min/1.73 m2 or age/gender-based serum creatinine limits
- Adequate liver function: Bilirubin ≤ 1.5 times upper limit of normal, ALT ≤ 135 U/L, serum albumin ≥ 2 g/dL
- Females of reproductive potential must use effective contraception during and for one month after larotrectinib treatment
- Males with partners of child-bearing potential must use effective contraception during and for one month after larotrectinib treatment
You will not qualify if you...
- No prior systemic therapy for thyroid cancer including TRK inhibitors; prior 131I therapy allowed
- Pregnant or breastfeeding females
- Current use of strong CYP3A4 inducers or inhibitors; these must be avoided 14 days before and during study treatment
AI-Screening
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Trial Site Locations
Total: 5 locations
1
University of California, San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 19807
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
M
Meghan Donnelly
CONTACT
J
James Robinson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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