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Study on the Safety and Effectiveness of Repotrectinib for Patients with ROS1-Positive Non-Small Cell Lung Cancer and Active Brain Metastasis

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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 lung cancer known as ROS1-positive non-small cell lung cancer (NSCLC) that has spread to the brain, referred to as brain metastasis. The treatment being tested in this study is a medication called Repotrectinib, also known by its code name TPX-0005. Repotrectinib is a type of drug known as a Tyrosine Kinase Inhibitor, which works by blocking certain proteins that help cancer cells grow.

The purpose of this study is to evaluate how effective Repotrectinib is in treating patients with this specific type of lung cancer that has spread to the brain. Participants in the study will take Repotrectinib in the form of a hard capsule, which is taken orally. The study will monitor the safety and effectiveness of the treatment over a period of time, with the maximum treatment period being 36 months. During the study, participants will have regular check-ups to assess their response to the treatment and to monitor any side effects.

This study aims to provide valuable information on the potential benefits of Repotrectinib for patients with ROS1-positive NSCLC with brain metastasis. The findings could help improve treatment options for this challenging condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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, the patient must provide a signed informed consent form, indicating understanding of the study's purpose.

    The patient must meet specific health criteria, including a performance status of 2 or less, a life expectancy of at least 6 weeks, and adequate bone marrow, liver, and kidney function.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm the presence of ROS1-positive non-small cell lung cancer with active brain metastasis.

    A tumor biopsy sample may be collected if feasible, and the patient must have measurable disease according to specific criteria.

  3. Step 3

    Treatment initiation

    The patient begins treatment with Repotrectinib (TPX-0005), administered orally in the form of hard capsules.

    The dosage and frequency of administration are determined by the study protocol, and the patient must be able to swallow the capsules intact.

  4. Step 4

    Ongoing treatment and monitoring

    Throughout the study, the patient receives regular monitoring to assess the treatment's effectiveness and any side effects.

    The primary goal is to evaluate the response of brain metastases to the treatment, with additional assessments of overall health and tumor response.

  5. Step 5

    Completion of study participation

    The study is estimated to conclude by April 2027, with the patient's participation ending upon completion of the treatment protocol or earlier if necessary.

    Final assessments are conducted to evaluate the overall outcomes of the treatment and any long-term effects.

Who can join the trial?

19 criteria

  • The patient must understand the purpose of the study and sign a written informed consent form before starting any study procedures.
  • The patient should have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2 or less. This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • The patient must have a minimum life expectancy of 6 weeks or more at the time of screening.
  • There is no limit on the number of previous treatments like chemotherapy or immunotherapy, except the patient must not have received any treatment specifically targeting ROS1.
  • The patient must have a left ventricular ejection fraction (LVEF) of 50% or more, which is a measure of how well the heart is pumping blood, determined by an echocardiogram or a multigated acquisition scan.
  • If possible, a sample of the tumor tissue should be provided at the start of the study.
  • The patient must have adequate bone marrow, liver, and kidney function. This includes specific blood counts and liver and kidney function tests within certain limits.
  • Any side effects from previous cancer treatments must have resolved to a mild level, except for hair loss or other effects that are not considered a safety risk.
  • The patient must be 18 years or older at the time of signing the consent form.
  • Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use effective birth control during the study and for 2 months after the last treatment. They must also not donate eggs or breastfeed during this time.
  • Men who are sexually active with women who can become pregnant must use effective birth control during the study and for 4 months after the last treatment. They must also not donate sperm during this time.
  • The patient must be available for treatment and follow-up visits.
  • The patient must be able to swallow capsules whole without chewing, crushing, or opening them.
  • The patient must have a confirmed diagnosis of non-small cell lung cancer (NSCLC) through a tissue sample.
  • The patient may have symptoms related to cancer spread to the brain.
  • The patient should not need immediate local treatment like surgery or radiation for brain metastases, unless discussed with the study's medical monitor.
  • Patients with a specific type of cancer spread to the brain lining, known as Type II leptomeningeal disease, are allowed.
  • The patient must have a confirmed ROS1 rearrangement, which is a specific genetic change in the cancer, confirmed by a certified laboratory using certain tests.
  • The patient must have measurable disease in the brain according to specific criteria, with at least one brain lesion that is 10 mm or larger on an MRI scan.

Who cannot join the trial?

3 criteria

  • Patients with **active brain metastasis** cannot participate. This means that the cancer has spread to the brain and is currently causing symptoms or growing.
  • Patients who are not diagnosed with **ROS1-positive non-small cell lung cancer (NSCLC)** are excluded. This is a specific type of lung cancer that has a particular genetic change called ROS1.
  • Patients who are part of a **vulnerable population** are not eligible. This generally refers to groups who may need special protection, like children or those unable to give consent.
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Investigated drugs

REPotrectinib is a medication being studied for its effectiveness in treating patients with a specific type of lung cancer known as ROS1-positive non-small cell lung cancer. This study is particularly focused on patients who have cancer that has spread to the brain. The goal is to see how well this medication works in reducing or eliminating cancer in the brain.

What is already known about the treatment

Repotrectinib – Repotrectinib is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically in a phase II study known as the REPOSE study, to evaluate its safety and effectiveness. The main therapeutic indication for Repotrectinib is for treating ROS1-positive non-small cell lung cancer (NSCLC) in patients who have active brain metastasis. At the molecular level, Repotrectinib works by inhibiting specific proteins that promote cancer cell growth, particularly targeting the ROS1 protein. It is classified pharmacologically as a tyrosine kinase inhibitor, which helps to block the signals that lead to cancer cell proliferation.

Investigated diseases

ROS1-positive non-small cell lung cancer (NSCLC) with active brain metastasis – This is a type of lung cancer characterized by the presence of a specific genetic alteration known as ROS1 rearrangement. It primarily affects the lungs but can spread to other parts of the body, including the brain, leading to metastasis. The disease progresses as cancer cells grow uncontrollably in the lungs and may invade nearby tissues or spread to distant organs. Brain metastasis occurs when cancer cells travel through the bloodstream or lymphatic system to the brain, forming new tumors. This can lead to neurological symptoms due to the pressure and damage caused by the growing tumors in the brain. The progression of the disease can vary, with some patients experiencing rapid growth and others having a slower course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508112-35-00Protocol codeMEDOPP662Estimated enrolment20 patientsSponsorMedica Scientia Innovation Research S.L.

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