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Study of Tepotinib and Osimertinib for Patients with Advanced or Metastatic Lung Cancer Resistant to Osimertinib Therapy

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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 the cancer has advanced or spread to other parts of the body and has certain genetic changes called EGFR mutations. These mutations can make the cancer resistant to previous treatments. The trial is testing a combination of two medications: osimertinib, which is already used to treat this type of cancer, and tepotinib, which is being studied for its potential to help when the cancer has become resistant to osimertinib.

The purpose of the study is to see how effective the combination of tepotinib and osimertinib is in treating this specific type of lung cancer. Participants in the study will take these medications in the form of film-coated tablets. The study will follow participants over a period of time to observe how their cancer responds to the treatment. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active drug. The study will also monitor for any side effects or changes in health that may occur during the treatment.

Throughout the study, participants will have regular check-ups to assess their health and the progress of their cancer. This will include various tests and assessments to ensure the safety and effectiveness of the treatment. The study aims to provide valuable information on whether this combination of medications can offer a new treatment option for patients with this challenging form of 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including having advanced or metastatic non-small cell lung cancer (NSCLC) with certain genetic characteristics.

    A performance status assessment is conducted to ensure the ability to participate in the study.

  2. Step 2

    Initial assessments

    Initial assessments include the collection of tumor tissue and blood samples to confirm specific genetic markers.

    These samples are used to determine the presence of MET amplification, which is necessary for participation.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of two medications: osimertinib and tepotinib, both taken orally.

    The dosage for osimertinib is either 80 mg or 40 mg, depending on the specific requirements of the study.

  4. Step 4

    Ongoing treatment

    The treatment continues with regular administration of the medications as prescribed.

    Participants are monitored for any side effects or changes in health status.

  5. Step 5

    Regular evaluations

    Regular evaluations are conducted to assess the response to treatment, including imaging tests to monitor tumor size and progression.

    Health-related quality of life is also assessed using specific questionnaires.

  6. Step 6

    Completion of study

    The study is estimated to conclude by June 2025, at which point final assessments are conducted.

    Participants' overall health and response to treatment are evaluated to determine the study's outcomes.

Who can join the trial?

8 criteria

  • The patient must have a type of lung cancer called **Non-small Cell Lung Cancer (NSCLC)**, which is confirmed by examining tissue or cells from the lung.
  • The patient must have a specific change in their cancer called an **activating Epidermal Growth Factor Receptor (EGFR) mutation**.
  • The patient should have a **performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work. They should also have a life expectancy of at least 12 weeks.
  • The patient must have developed resistance to a previous treatment called **osimertinib**. This means their disease got worse while on osimertinib, but they had some benefit from it before, like a reduction in tumor size or stable disease for more than 6 months.
  • The patient should have only received osimertinib as their first treatment for advanced or metastatic NSCLC that cannot be cured.
  • The patient must have a condition called **MET amplification**, which is a change in the cancer cells. This must be confirmed by a test called **FISH** or by a blood test using advanced sequencing techniques.
  • The patient must provide samples of their tumor tissue and blood after their disease got worse on osimertinib for testing MET amplification.
  • If the patient's tumor was tested locally for MET amplification, they must provide tumor tissue during the prescreening or screening phase to confirm the MET amplification status.
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Investigated drugs

  • Tepotinib

    is a medication used in this study to target and inhibit the MET protein, which can be amplified in certain types of cancer cells. By blocking this protein, tepotinib aims to slow down or stop the growth of cancer cells in patients with non-small cell lung cancer (NSCLC) that have specific genetic changes.

  • Osimertinib

    is a medication that targets and inhibits the activity of the EGFR protein, which is often mutated in non-small cell lung cancer. This medication is used to treat patients whose cancer has specific EGFR mutations, helping to control the growth and spread of cancer cells. In this study, osimertinib is combined with tepotinib to enhance its effectiveness in patients who have developed resistance to previous osimertinib therapy.

What is already known about the treatment

  • Tepotinib

    Tepotinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. The medication works by inhibiting the MET receptor tyrosine kinase, which plays a role in cancer cell growth and survival. Tepotinib is classified as a MET inhibitor and is being explored for its potential to overcome resistance to other cancer therapies.

  • Osimertinib

    Osimertinib is taken orally as a tablet. It is an established treatment for certain types of non-small cell lung cancer (NSCLC) with specific mutations in the EGFR gene. The drug functions by blocking the activity of the EGFR tyrosine kinase, which is involved in the growth and spread of cancer cells. Osimertinib is classified as a third-generation EGFR inhibitor and is widely used in clinical practice for its targeted action against cancer cells with EGFR mutations.

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. The disease can spread to other parts of the body, a process known as metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the more common. The progression of lung cancer can vary, with some tumors growing slowly over time, while others may spread quickly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512005-87-00Protocol codeMS200095-0031Estimated enrolment104 patientsSponsorMerck Healthcare KGaA

sourced from the EU Clinical Trials Register and site verification

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