Study on Using Larotrectinib to Improve Radioactive Iodine Treatment in Differentiated Thyroid Cancer

Sponsor: Children's Hospital of Philadelphia

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05783323

Provider View

This clinical trial is exploring whether the drug larotrectinib can enhance the effectiveness of radioactive iodine (RAI) therapy in patients with differentiated thyroid cancer, particularly those with lung metastases.

Patient Parameters

Program Overview

This study aims to test if larotrectinib, when used before radioactive iodine (RAI) therapy, can improve treatment outcomes for patients with differentiated thyroid cancer that has spread to the lungs. The focus is on patients with a specific genetic change called NTRK fusion. The trial will assess how well the combination treatment works and its safety over an 18-month period.

Description

This clinical trial is open to patients with differentiated thyroid cancer that has a specific genetic change known as NTRK fusion. The study will test the safety and effectiveness of using the drug larotrectinib before giving radioactive iodine (RAI) therapy. The main goal is to see if this combination can improve lung health in patients over 18 months. Participants will take larotrectinib for six months, followed by RAI therapy. The study is open-label, meaning both the researchers and participants know what treatment is being given.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 1 year old.
  • Have a confirmed diagnosis of differentiated thyroid cancer and have had surgery and appropriate local treatment for cancer in the neck.
  • Have lung nodules visible on a CT scan that meet specific criteria, such as multiple non-calcified nodules or enlarging nodules.
  • Have a specific genetic change called NTRK fusion, confirmed by a certified lab.
  • Have a performance status score of at least 50%, indicating the ability to carry out daily activities.
  • Have adequate organ function, including:
    • Bone marrow function with specific blood cell counts.
    • Kidney function with creatinine levels within specified limits based on age and gender.
    • Liver function with bilirubin and enzyme levels within specified limits.
  • Female participants of childbearing potential must agree to use effective birth control during the study and for one month after the last dose of larotrectinib. Male participants with partners of childbearing potential must also use effective contraception during the study and for one month after the last dose.

Exclusion Criteria

  • No previous systemic treatment for thyroid cancer, including certain targeted therapies or radioactive iodine.
  • Women who are pregnant or breastfeeding cannot participate due to potential risks to the baby.
  • Participants cannot be taking certain medications that affect liver enzymes, specifically strong CYP3A4 inducers or inhibitors, during the study.

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