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Study on How Larotrectinib Works in Adults with Solid Tumors with NTRK Gene Fusion

Fast replyInvestigationalNo 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 the effectiveness of a drug called Larotrectinib in treating adults with various types of solid cancers that have a specific genetic change known as NTRK fusion. Solid cancers are tumors that form in solid organs or tissues, such as the breast, lung, or colon, as opposed to blood cancers like leukemia. The genetic change, NTRK fusion, involves the joining of an NTRK gene with another gene, which can lead to cancer growth. The drug Larotrectinib is designed to target and inhibit the activity of these fused genes, potentially stopping or slowing the growth of the cancer.

The purpose of this study is to learn how well Larotrectinib works in treating these cancers. Participants in the study will receive Larotrectinib in the form of an oral solution or a hard capsule. The study will monitor the participants' response to the treatment over a period of time, looking for signs of tumor shrinkage or stabilization. Some participants may receive a placebo, which is a substance with no active drug, to compare the effects of Larotrectinib against no treatment. The study aims to determine the overall response rate, which is the proportion of participants who experience a significant reduction in tumor size or complete disappearance of the tumor.

Throughout the study, participants will have regular check-ups and imaging tests, such as MRI or computed tomography (CT), to assess the size and progression of their tumors. The study will also evaluate the duration of response, which is how long the tumor remains reduced in size, and other outcomes like progression-free survival, which is the length of time during and after treatment that the cancer does not worsen. The safety of Larotrectinib will be closely monitored, with any side effects being recorded and analyzed. The study is expected to continue until October 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, the first step involves an initial visit to the clinic. During this visit, the patient will be asked to provide informed consent. This means agreeing to participate in the study after understanding all the details, including potential risks and benefits.

    The patient will also undergo a series of tests to confirm eligibility. These tests may include imaging studies and laboratory tests to ensure the patient meets the study criteria.

  2. Step 2

    Treatment initiation

    Once eligibility is confirmed, the patient will begin treatment with the study medication, larotrectinib. This medication is taken orally, either as a solution or in capsule form.

    The dosage and frequency will be determined by the study protocol, and the patient will be instructed on how to take the medication correctly.

  3. Step 3

    Regular follow-up visits

    Throughout the study, the patient will attend regular follow-up visits. These visits are crucial for monitoring the patient's health and the effectiveness of the treatment.

    During these visits, the patient will undergo various assessments, including physical exams, imaging studies, and laboratory tests. The frequency of these visits will be specified in the study protocol.

  4. Step 4

    Response evaluation

    The patient's response to the treatment will be evaluated using specific criteria. This involves assessing any changes in the size of the tumor or other indicators of disease progression.

    The evaluation will be conducted by an independent radiology review committee, ensuring an objective assessment of the treatment's effectiveness.

  5. Step 5

    End of treatment

    The treatment phase will continue until a specified endpoint is reached, such as disease progression or completion of the treatment duration outlined in the study protocol.

    At the end of the treatment phase, the patient will undergo a final assessment to determine the overall response to the medication.

  6. Step 6

    Post-treatment follow-up

    After completing the treatment, the patient may be required to attend additional follow-up visits. These visits help monitor the patient's long-term health and any lasting effects of the treatment.

    The duration and frequency of post-treatment follow-up will be determined by the study protocol.

Who can join the trial?

11 criteria

  • Have a locally-advanced or metastatic cancer with an NTRK1, NTRK2, or NTRK3 gene fusion. This means that the cancer has a specific genetic change that can be identified through special lab tests.
  • Be able to give signed informed consent, which means you understand the study and agree to participate.
  • If joining the bone health group, have a life expectancy of at least 6 months, as assessed by the doctor.
  • Have received previous standard treatments for your type and stage of cancer, or have no other satisfactory treatment options available.
  • Have at least one measurable tumor, which means a tumor that can be measured in size using medical imaging techniques.
  • Be at least 18 years old.
  • Have a Performance Status score of 3 or less, which is a measure of your ability to perform daily activities. If you have a primary brain tumor, a Karnofsky Performance Score of 50% or more is required.
  • Provide a sample of your tumor tissue before starting treatment. If a fresh sample cannot be obtained, previous samples may be used after discussing with the study sponsor.
  • Have adequate organ function, which means your liver and kidneys are working well enough, as shown by specific blood tests.
  • Be able to comply with outpatient treatment, which means you can attend clinic visits and follow the study requirements.
  • If you are a man or woman who can have children, agree to use two effective methods of birth control during the study and for one month after the study ends.

Who cannot join the trial?

4 criteria

  • Patients who do not have solid tumors with an NTRK fusion cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. NTRK fusion refers to a specific genetic change in the tumor.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so it's important to check if you fall within these groups.
  • Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results cannot participate.
  • Patients who are part of a vulnerable population, which may include groups like children or those unable to give consent, may not be eligible unless specific conditions are met.
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Investigated drugs

Larotrectinib is a medication used in this clinical trial. It is an oral drug that targets specific proteins in cancer cells known as TRK proteins. These proteins can become abnormal due to changes in certain genes called NTRK1, NTRK2, or NTRK3. When these genes fuse with other genes, they can cause cancer cells to grow. Larotrectinib works by blocking the activity of these TRK proteins, which may help stop the growth of cancer cells or even shrink the tumors. This medication is being tested to see how well it works in treating patients with advanced cancers that have these specific genetic changes.

What is already known about the treatment

Larotrectinib – Larotrectinib is an oral medication, meaning it is taken by mouth, and is currently being studied in clinical trials for its effectiveness in treating solid tumors that have a specific genetic feature known as NTRK fusion. This medication is still under investigation, but it has shown promise in medical studies for its ability to shrink tumors in patients with this genetic characteristic. Larotrectinib works by blocking the action of certain proteins that help cancer cells grow, specifically targeting the TRK proteins that are produced due to the NTRK fusion. It is classified as a TRK inhibitor, which is a type of targeted cancer therapy designed to interfere with specific molecules involved in the growth and spread of cancer.

Investigated diseases

Solid Tumors Harboring NTRK Fusion – Solid tumors with NTRK fusion are a type of cancer characterized by the presence of a genetic alteration involving the NTRK1, NTRK2, or NTRK3 genes. These tumors can occur in various parts of the body and are not limited to a specific organ or tissue. The fusion of NTRK genes leads to the production of abnormal proteins that can drive the growth and spread of cancer cells. As the disease progresses, these tumors may increase in size and potentially spread to other areas of the body. The progression can vary significantly depending on the tumor's location and the specific characteristics of the NTRK fusion. Monitoring the tumor's response to treatment is crucial in managing the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502667-38-00Protocol code20289Estimated enrolment210 patientsSponsorBayer AG

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