Actively Recruiting
Larotrectinib to Enhance RAI Avidity in Patients With Differentiated Thyroid Cancer Harboring NTRK Fusions (LANTERN)
Led by Children's Hospital of Philadelphia · Updated on 2025-11-14
13
Participants Needed
5
Research Sites
52 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 type of differentiated thyroid cancer (DTC). Traditional treatment after surgery includes radioactive iodine (RAI) therapy, but it is effective in less than 25% of patients with lung metastases and carries risks such as lung scarring and secondary cancers. This study evaluates the combination of larotrectinib followed by RAI therapy in patients with differentiated thyroid cancer that has a specific NTRK gene fusion. Participants will receive larotrectinib alone for 6 months at the FDA-approved dose. After this period, they will undergo 131I (radioactive iodine) therapy while continuing larotrectinib for 5 more days. Those who experience disease progression during larotrectinib treatment will stop it and proceed directly to 131I therapy. Following treatment, patients will enter a monitoring phase without active therapy. During the study, patients will have chest CT scans to assess lung disease and other evaluations to monitor safety and treatment response. The primary outcome is the number of patients achieving a complete structural response in the lungs at 18 months. Participants will be followed throughout treatment and observation periods, with assessments including performance status and organ function tests to ensure safety and measure outcomes.
CONDITIONS
Brief 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 therapy for metastatic neck disease
- Anatomically evaluable lung disease on chest CT showing multiple (>10) or enlarging pulmonary nodules consistent with metastases
- Presence of NTRK gene fusion confirmed by an accredited lab without kinase resistance mutations
- Lansky/Karnofsky performance status of 50% or higher
- Adequate bone marrow function with ANC ≥ 1000/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 8.0 g/dL
- Adequate renal function with creatinine clearance or GFR ≥ 70 mL/min/1.73 m2 or age/gender-based serum creatinine limits
- Adequate liver function with bilirubin ≤ 1.5 times upper limit of normal, ALT ≤ 135 U/L, and serum albumin ≥ 2 g/dL
- Female participants of reproductive potential must agree to use effective contraception during and for 1 month after treatment; males with partners of childbearing potential must do the same
You will not qualify if you...
- No prior systemic therapy for thyroid cancer, including TRK inhibitors; prior radioactive iodine therapy is allowed
- Pregnant or breastfeeding females
- Concurrent use of strong CYP3A4 inducers or inhibitors; these must be avoided 14 days before and during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months plus additional days for post-therapy larotrectinib
Participants receive larotrectinib monotherapy for 6 months followed by 131I therapy. Larotrectinib is continued for 5 days after 131I therapy before participants enter a wait and see period off treatment.
Regular visits during larotrectinib and 131I therapy as per protocol
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
J
James Robinson
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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