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Study of Tepotinib for Patients with Advanced Lung Cancer with MET Exon 14 Skipping Alterations or MET Amplification

Verified siteInvestigationalNo 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 lung cancer known as non-small cell lung cancer (NSCLC). The study is specifically looking at cases where there are changes in the cancer cells called MET exon 14 skipping alterations or MET amplification. These changes can affect how the cancer grows and responds to treatment. The treatment being tested in this study is a medication called Tepotinib, which is taken as a film-coated tablet. Tepotinib is designed to target these specific changes in the cancer cells.

The purpose of the study is to evaluate how effective Tepotinib is in treating patients with advanced stages of NSCLC that have these specific genetic changes. The study is divided into different parts, each focusing on different groups of patients based on their specific genetic changes. Patients will receive Tepotinib and will be monitored to see how their cancer responds to the treatment. The study will also look at how long the response lasts and how the treatment affects the overall health and quality of life of the participants.

Participants in the study will take Tepotinib orally, and the treatment period can last up to 63 days. The study aims to gather information on the safety and effectiveness of Tepotinib in treating this type of lung cancer. By participating in this study, researchers hope to better understand how Tepotinib can be used to help patients with these specific genetic changes in their lung cancer.

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

    Enrollment

    Upon joining the study, confirmation of advanced lung cancer is required. This includes locally advanced or metastatic non-small cell lung cancer (NSCLC).

    Eligibility is determined by specific genetic alterations in the MET gene, identified through blood or tissue tests.

  2. Step 2

    Initial Assessment

    An initial assessment is conducted to evaluate the disease status using imaging techniques. This is done according to a standardized method known as RECIST version 1.1.

    The patient's overall health and ability to perform daily activities are assessed using the Eastern Cooperative Oncology Group Performance Status (ECOG PS).

  3. Step 3

    Treatment Administration

    The medication tepotinib is administered orally in the form of film-coated tablets.

    The dosage and frequency of administration are determined by the study protocol and the patient's specific condition.

  4. Step 4

    Monitoring and Evaluation

    Regular monitoring is conducted to assess the response to treatment. This includes imaging studies and laboratory tests.

    The primary goal is to evaluate the objective response, which includes complete or partial reduction of the tumor size.

  5. Step 5

    Follow-up

    The duration of response and overall survival are tracked over time.

    The patient's quality of life and any side effects experienced are also monitored.

  6. Step 6

    Study Completion

    The study is expected to conclude by June 2025.

    Final assessments will be conducted to determine the long-term effects and benefits of the treatment.

Who can join the trial?

9 criteria

  • The patient must have **advanced lung cancer**, which means the cancer has spread locally or to other parts of the body. This includes all types of lung cancer, such as squamous and sarcomatoid.
  • The patient can either be new to treatment (first-line) or have had no more than two previous treatments.
  • The patient must have specific changes in the **MET gene**, known as METex14 skipping alterations, found in blood or tissue samples. These changes must be confirmed by a central laboratory or an approved test.
  • The patient must provide signed, written consent to participate in the study.
  • The patient must be at least 18 years old, or older if the local laws require it. For example, in Japan, the patient must be at least 20 years old.
  • The patient must have measurable disease according to a standard method called **RECIST version 1.1**, which is used to assess how well the cancer responds to treatment.
  • The patient must have an **ECOG Performance Status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Female patients must not be pregnant or breastfeeding. They must either not be able to have children or agree to use highly effective birth control methods before and during the study, and for at least 4 weeks after the last treatment. They must also have a negative pregnancy test before joining the study.
  • Male patients must agree to use highly effective birth control methods and ensure their female partners do the same during the study and for at least 3 months after the last treatment. They should also avoid donating sperm during this time.

Who cannot join the trial?

5 criteria

  • Patients who do not have **lung cancer** cannot participate.
  • Patients who do not have specific genetic changes called **METex14 skipping alterations** or **MET amplification** in their lung cancer cannot participate.
  • Patients who are not in the age range specified for the study cannot participate. The study is for adults.
  • Patients who are not able to give their own consent or are considered part of a vulnerable group may not be able to participate.
  • Both men and women can participate, so gender is not a reason for exclusion.
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Investigated drugs

Tepotinib is a medication being studied for its effectiveness in treating advanced non-small cell lung cancer (NSCLC). This trial focuses on patients whose cancer has specific genetic changes known as MET exon 14 skipping alterations or MET amplification. Tepotinib works by targeting these genetic changes, which can help slow down or stop the growth of cancer cells. The trial aims to see how well tepotinib can reduce the size of tumors in patients with these specific genetic profiles.

What is already known about the treatment

Tepotinib – Tepotinib is an oral medication currently being studied for its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with specific genetic changes known as MET exon 14 skipping alterations or MET amplification. It is in the clinical trial phase, with ongoing research to determine its efficacy and safety. The main therapeutic indication for tepotinib is lung cancer, particularly in cases where these genetic alterations are present. At the molecular level, tepotinib works by inhibiting the MET receptor tyrosine kinase, which is involved in the growth and spread of cancer cells. It is classified as a targeted cancer therapy, focusing on specific molecular targets associated with cancer.

Investigated diseases

Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung's ability to provide oxygen to the bloodstream. Lung cancer can be classified into two main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being more common. The disease may spread to other parts of the body, a process known as metastasis. Symptoms often include persistent cough, chest pain, and shortness of breath.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512003-39-00Protocol codeMS200095-0022Estimated enrolment126 patientsSponsorMerck Healthcare KGaA

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