#1 Clinical Trials Search in Europe

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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Pius-Hospital Oldenburg Oldenburg In Holstein Germany
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Asklepios Klinik Gauting GmbH Gauting Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
Universita’ Di Pisa Pisa Italy
Hopital Beaujon Clichy France
Iepixzkz Ckqudc Dwiieznehkcokcppw L'hospitalet De Llobregat Spain
Uikeeppuhc Of Aiplfpb Edegem Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.07.2019
France France
Not recruiting
01.07.2019
Germany Germany
Not recruiting
01.07.2019
Italy Italy
Not recruiting
01.07.2019
Spain Spain
Not recruiting
01.07.2019

Trial locations

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.

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 ID:
2024-512005-87-00
Protocol code:
MS200095-0031
NCT ID:
NCT03940703
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Adjuvant mRNA-4157 and pembrolizumab for patients with completely resected high‑risk stage I non‑small cell lung cancer

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Hungary Italy The Netherlands +2

  • Study on the Effectiveness and Safety of Nemtabrutinib for Patients with Blood Cancers, Including CLL, SLL, MCL, MZL, FL, and Waldenström’s Macroglobulinemia

    Recruiting

    2 1 1 1
    Investigated diseases:
    Czechia Denmark France Germany Hungary Ireland +4