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Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

Fast replyRegistered 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 treating patients with certain types of advanced cancers, specifically those that have a change in a gene called Rearranged During Transfection (RET). The cancers being studied include Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Breast Cancer, Pancreatic Cancer, Papillary Thyroid Cancer, and other solid tumors with this specific gene change. The treatment being tested is a medication called selpercatinib, which is taken as a capsule by mouth.

The purpose of this study is to provide access to selpercatinib for patients who have these advanced cancers with the RET gene change. The study is designed to help patients who are not eligible for other ongoing clinical trials of selpercatinib. Participants will take the medication over a period of time, and their health will be monitored by their healthcare team. The study does not involve any specific data analysis or endpoints, meaning it is primarily focused on providing the treatment rather than collecting data for research purposes.

Patients who participate in this study will receive selpercatinib as part of an expanded access program, which is a way to provide treatment to patients who have no other options available. The treatment period can last up to 84 days, and the medication is taken orally. This study aims to support patients with advanced cancers by offering them a potential treatment option when other therapies are not suitable or available.

The research process

The trial runs in 4 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, the patient must provide a signed informed consent. This consent is necessary before any specific procedures related to the study can begin.

    The patient must be 18 years of age or older and have a diagnosis of a locally advanced or metastatic tumor with a specific genetic change known as RET alteration.

  2. Step 2

    Eligibility confirmation

    The patient must not be eligible for any ongoing clinical trials involving selpercatinib due to various reasons such as clinical, geographic, or financial constraints.

    The patient must have progressed on, be intolerant to, or have no standard therapy available. Adequate blood, kidney, and liver function are required.

  3. Step 3

    Treatment with selpercatinib

    The patient will receive selpercatinib, which is administered orally. The specific dosage and frequency will be determined by the treating physician.

    The treatment will continue for the duration of the study, which is estimated to end on November 3, 2024.

  4. Step 4

    Birth control requirements

    Patients of childbearing potential must use double effective birth control methods during the treatment and for three months after the last dose. This involves one method used by the patient and another by their partner.

Who can join the trial?

8 criteria

  • The patient must have a tumor that is either locally advanced or has spread to other parts of the body. The tumor must show evidence of a change in the **RET gene** that makes it active.
  • The patient is not eligible for another ongoing clinical trial with the drug **selpercatinib** due to reasons like location, cost, or the trial being closed, but is considered a good candidate for this treatment by their doctor and the study sponsor.
  • The patient has tried standard treatments, but they did not work, or the patient cannot tolerate them, or there are no standard treatments available.
  • The patient must be 18 years old or older.
  • The patient must have good blood, kidney, and liver function as defined in the study guidelines.
  • The patient or their legally authorized representative must be able to give consent to participate in the study.
  • The patient must provide a signed informed consent before any study-specific procedures are done.
  • Men and women who can have children must agree to use two effective methods of birth control, one used by the patient and another by their partner, during the treatment and for 3 months after the last dose.

Who cannot join the trial?

6 criteria

  • Patients who are younger than 18 years old cannot participate.
  • Patients without a diagnosis of a solid tumor with an activating RET alteration cannot participate. An activating RET alteration is a specific change in the RET gene that can cause cancer cells to grow.
  • Patients who are not able to understand or agree to the study requirements cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
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Investigated drugs

Selpercatinib is a medication used in this clinical trial to treat patients with locally advanced or metastatic solid tumors that have specific genetic changes known as RET alterations. This medication is designed to target and inhibit the activity of the RET protein, which can help slow down or stop the growth of cancer cells. The trial aims to provide access to this treatment for patients who meet the criteria.

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 various types of cancer, including non-small cell lung cancer, medullary thyroid cancer, colon cancer, breast cancer, pancreatic cancer, papillary thyroid cancer, and other solid tumors with RET alterations. It is classified as a targeted therapy and works by inhibiting the activity of the RET protein, which is involved in cell growth and division. By blocking this protein, selpercatinib can help slow down or stop the growth of cancer cells. The medication is part of an expanded access program, providing treatment options for patients with advanced or metastatic tumors that have specific genetic changes.

Investigated diseases

  • Non-Small Cell Lung Cancer

    This is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and difficulty breathing.

  • Medullary Thyroid Cancer

    A rare form of thyroid cancer that originates from the parafollicular C cells of the thyroid gland. It can occur sporadically or as part of a genetic syndrome. The disease may present with a neck mass, difficulty swallowing, or changes in voice. It can spread to lymph nodes and other organs.

  • Colon Cancer

    This cancer starts in the colon or rectum, parts of the large intestine. It often begins as small, benign clumps of cells called polyps, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort.

  • Breast Cancer

    A common cancer that forms in the cells of the breasts, often in the ducts or lobules. It can spread to other parts of the body if not detected early. Symptoms may include a lump in the breast, changes in breast shape, or skin dimpling.

  • Pancreatic Cancer

    This cancer begins in the tissues of the pancreas, an organ that lies behind the lower part of the stomach. It often goes undetected until it is advanced due to its location. Symptoms may include jaundice, weight loss, and abdominal pain.

  • Papillary Thyroid Cancer

    The most common type of thyroid cancer, arising from follicular cells. It generally grows slowly and is often found in one lobe of the thyroid gland. Symptoms may include a lump in the neck, trouble swallowing, or hoarseness.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507678-42-00Protocol codeLOXO-RET-18037Estimated enrolment554 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

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