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Study Comparing Selpercatinib, Cabozantinib, and Vandetanib for Patients with Advanced RET-Mutant Medullary Thyroid Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of thyroid cancer known as RET-mutant medullary thyroid cancer. This is a specific form of thyroid cancer that is caused by changes in the RET gene. The study is comparing the effectiveness of a new treatment called Selpercatinib with two other existing treatments, Cabozantinib and Vandetanib. These treatments are known as kinase inhibitors, which are medications that can block certain proteins in cancer cells and may help to stop the cancer from growing.

The purpose of the study is to see how well Selpercatinib works compared to the other two treatments in patients who have not previously been treated with kinase inhibitors. Participants in the study will be randomly assigned to receive either Selpercatinib, Cabozantinib, or Vandetanib. The study will monitor the progress of the cancer and how it responds to the treatment over time. The treatments are taken orally, meaning they are swallowed in the form of a pill or capsule.

The study will take place over a period of time, and participants will have regular check-ups to monitor their health and the status of their cancer. The goal is to determine which treatment is most effective in slowing down or stopping the growth of the cancer. This information could help improve treatment options for people with RET-mutant medullary thyroid cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. This includes having medullary thyroid cancer that cannot be surgically removed or has spread, and showing growth in the last 14 months.

    Confirmation of a mutation in the RET gene is required. General health must be fair to good, without other serious medical conditions.

    Commitment to using highly effective contraception during the study is necessary.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either selpercatinib or a physician's choice of cabozantinib or vandetanib.

  3. Step 3

    Treatment administration

    Selpercatinib is administered orally. The dosage and frequency are determined by the study protocol.

    Cabozantinib is also administered orally, with dosage and frequency as per the study protocol.

    Vandetanib is administered orally, following the study's specified dosage and frequency.

  4. Step 4

    Monitoring and assessments

    Regular monitoring and assessments are conducted to evaluate the progression of the cancer and the effectiveness of the treatment.

    Imaging studies and other tests are performed periodically to track changes in the cancer.

  5. Step 5

    End of study participation

    The study is estimated to conclude on November 13, 2027. Participation continues until this date or until specific criteria for discontinuation are met.

Who can join the trial?

7 criteria

  • Participants must have **medullary thyroid cancer** that cannot be removed by surgery or has spread to other parts of the body.
  • The cancer must not have been treated with certain medications before.
  • There must be proof from imaging studies that the cancer has grown in the last 14 months.
  • Participants must have evidence that their cancer is caused by a **mutation** in the **RET gene**. A mutation is a change in the gene that can cause cancer.
  • Participants must be in fair to good general health and not have another serious medical condition.
  • Participants must be willing to use highly effective **contraception** during the study. Contraception refers to methods used to prevent pregnancy.
  • Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

  • Patients who have already been treated with a type of medication called a kinase inhibitor. A kinase inhibitor is a drug that blocks certain proteins in the body that can help cancer cells grow.
  • Patients who do not have a specific genetic change called a RET mutation in their medullary thyroid cancer. A RET mutation is a change in the DNA that can affect how cancer grows.
  • Patients who are not experiencing progressive cancer. Progressive cancer means that the cancer is getting worse or spreading.
  • Patients who are not considered to have advanced cancer. Advanced cancer is cancer that has spread from where it started to other parts of the body.
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Investigated drugs

  • Selpercatinib

    is a medication being tested in this trial for its effectiveness in treating patients with a specific type of thyroid cancer known as RET-mutant medullary thyroid cancer. It works by targeting and inhibiting certain proteins that are involved in the growth and spread of cancer cells.

  • Cabozantinib

    is another medication used in this trial. It is designed to slow down or stop the growth of cancer cells by blocking certain pathways that the cancer cells use to grow and spread.

  • Vandetanib

    is also part of this trial. It is used to treat thyroid cancer by interfering with the cancer cells' ability to grow and divide, helping to control the progression of the disease.

What is already known about the treatment

  • Selpercatinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating RET-mutant medullary thyroid cancer. It is a targeted therapy that works by inhibiting specific proteins involved in the growth and spread of cancer cells. Selpercatinib is classified as a kinase inhibitor, and it is designed to block the activity of the RET protein, which is often mutated in certain types of thyroid cancer. The medication is still under investigation, but it shows promise in improving progression-free survival in patients with this specific cancer type.

  • Cabozantinib

    Administered orally, cabozantinib is an approved medication used to treat various types of cancer, including medullary thyroid cancer. It functions by inhibiting multiple tyrosine kinases, which are enzymes that promote cancer cell growth and angiogenesis, the formation of new blood vessels that supply tumors. Cabozantinib is classified as a multi-kinase inhibitor and is used to slow down or stop the growth of cancer cells. It is part of ongoing research to compare its effectiveness against other treatments for RET-mutant medullary thyroid cancer.

  • Vandetanib

    This medication is taken orally and is approved for the treatment of medullary thyroid cancer. Vandetanib works by blocking certain proteins that are involved in the growth and spread of cancer cells, specifically targeting the RET, VEGFR, and EGFR pathways. It is classified as a tyrosine kinase inhibitor and is used to manage symptoms and slow the progression of cancer. Vandetanib is being compared in clinical trials to other treatments to determine its efficacy in patients with RET-mutant medullary thyroid cancer.

Investigated diseases

RET-Mutant Medullary Thyroid Cancer – This is a type of thyroid cancer that originates from the parafollicular C cells of the thyroid gland and is associated with mutations in the RET gene. It is a rare form of cancer that can occur sporadically or as part of a genetic syndrome. The disease typically progresses by forming a mass in the thyroid, which may lead to symptoms such as a lump in the neck, difficulty swallowing, or changes in voice. As the cancer advances, it may spread to nearby lymph nodes and other parts of the body. The progression of the disease can vary, with some cases remaining localized while others become more aggressive. Understanding the genetic mutation involved is crucial for determining the course of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506782-56-00Protocol codeJ2G-MC-JZJBEstimated enrolment273 patientsSponsorEli Lilly & Co.

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