Differentiated Thyroid Cancer study: Larotrectinib monotherapy vs 131I therapy
Official title Larotrectinib to Enhance RAI Avidity in Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT05783323
What this study is testing
What is Larotrectinib?
Larotrectinib is an investigational oral medicine being studied as a potential treatment for differentiated thyroid cancer with NTRK gene fusions. It is designed to block the activity of TRK proteins produced by NTRK gene fusions, which can drive tumor growth.
Also referred to as Vitrakvi.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if larotrectinib can make thyroid cancer cells take up more radioactive iodine, potentially improving treatment response.
- Who it's for
- People with differentiated thyroid cancer, including papillary thyroid cancer, who have already had surgery.
- What's involved
- Participants will take larotrectinib and then receive standard radioactive iodine therapy, with follow‑up scans and lab tests to check iodine uptake.
- Time commitment
- The trial lasts several months, with regular clinic visits for medication, iodine treatment, and monitoring.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 99
You may be able to join if
- Age ≥ 1 year
- Histologic diagnosis of a differentiated thyroid cancer, s/p thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of...
- Anatomically evaluable disease on chest CT meeting one of the following criteria (obtained within 90 days of enrollment): A.
- Identification of an neurotrophic tyrosine receptor kinase (NTRK) (NTRK1, NTRK2, or NTRK3) gene fusion in a CLIA/CAP accredited laboratory without...
- Lansky/Karnofsky performance status ≥ 50%
You likely can't join if
- No prior systemic therapy for thyroid cancer, including tropomyosin receptor kinase (TRK) inhibitors. Note that prior 131I is permitted.
- Females who are pregnant or breastfeeding are excluded due to the potential risks of larotrectinib and RAI to the fetus/neonate.
- Concurrent therapy: Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible.
See the full eligibility criteria
- Age ≥ 1 year
- 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...
- 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.
- 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
- Lansky/Karnofsky performance status ≥ 50%
- 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). B. Adequate Renal Function: Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2 or a maximum...
- 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
- 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.
- No prior systemic therapy for thyroid cancer, including tropomyosin receptor kinase (TRK) inhibitors. Note that prior 131I is permitted.
- Females who are pregnant or breastfeeding are excluded due to the potential risks of larotrectinib and RAI to the fetus/neonate.
- Concurrent therapy: Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Philadelphia, Pennsylvania, United States; Memphis, Tennessee, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.