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Study Comparing Tepotinib to Standard Treatment for Patients with Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer

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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 Advanced MET exon 14 Mutated Non-Small Cell Lung Cancer. The study aims to compare the effectiveness of a medication called tepotinib with other standard treatments that patients may have already received, such as immunotherapy or chemotherapy. Tepotinib is taken as a tablet, while the standard treatments include medications like nivolumab, gemcitabine, paclitaxel, docetaxel, atezolizumab, bevacizumab, pembrolizumab, vinorelbine, and pemetrexed, which are usually given through an intravenous infusion, meaning they are administered directly into a vein.

The purpose of this study is to see how well tepotinib works compared to these other treatments in patients who have already been treated with immunotherapy or platinum-based chemotherapy. The study will involve regular visits to the clinic, where patients will receive their assigned treatment and undergo various tests to monitor their health and the progress of their cancer. The study will last for a period of up to 24 months, during which the patients' response to the treatment will be closely observed.

Throughout the study, the main focus will be on how long patients live without their cancer getting worse, which is known as progression-free survival. Other aspects being looked at include the overall survival of patients, their quality of life, and any side effects they may experience from the treatments. The study will also track how long the benefits of the treatment last and how soon patients might need to switch to another treatment. This information will help doctors understand the best ways to treat this specific type of lung cancer in the future.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to provide informed, written, and signed consent. This consent confirms your understanding and agreement to participate in the trial. It must be signed before any procedures related to the study that are not part of normal patient management are performed.
Step 2
Initial assessments
You will undergo initial assessments to confirm eligibility. This includes checking your medical history, current health status, and specific criteria such as the presence of a MET exon 14 mutation in your lung cancer. These assessments ensure that you meet all the necessary conditions to participate in the trial.
Step 3
Treatment assignment
You will be randomly assigned to receive either tepotinib or a standard treatment chosen by the investigator. Tepotinib is taken orally in the form of film-coated tablets. The standard treatment may include medications such as nivolumab, gemcitabine, paclitaxel, docetaxel, atezolizumab, bevacizumab, pembrolizumab, vinorelbine, or pemetrexed, which are administered intravenously.
Step 4
Treatment administration
If you are assigned to the tepotinib group, you will take the medication orally as prescribed by your doctor. If you are in the standard treatment group, you will receive the medication intravenously, which means it will be given through a vein. The frequency and duration of the treatment will be determined by your doctor based on your specific needs and response to the treatment.
Step 5
Regular monitoring
Throughout the trial, you will have regular visits to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging tests to assess the progression of your cancer and any side effects you may experience.
Step 6
Quality of life assessments
Your quality of life will be assessed using questionnaires designed to understand how the treatment affects your daily life and well-being. These assessments will occur at specific intervals, such as at the start of the trial and at week 6.
Step 7
End of treatment
The treatment will continue until there is evidence of disease progression, unacceptable side effects, or you decide to withdraw from the study. At the end of the treatment, you will have a final assessment to evaluate your overall health and the outcomes of the trial.
Step 8
Follow-up
After completing the treatment, you will have follow-up visits to monitor your health and any long-term effects of the treatment. These visits are important to ensure your well-being and to gather additional information about the effectiveness and safety of the treatment.

Who can join the trial?

18 criteria

Provide a signed and dated consent form, showing you understand and agree to participate in the study.
Have a confirmed diagnosis of advanced Non-Small Cell Lung Cancer (NSCLC) with a specific genetic change called MET exon 14 mutation.
Show that the cancer has worsened after receiving at least one previous treatment, which could include chemotherapy with a drug called platinum or a type of treatment called immunotherapy.
Have received no more than two previous treatments for your cancer.
Have a Performance Status score between 0 and 3, which measures your ability to perform daily activities.
Brain metastases (cancer spread to the brain) are allowed if any necessary immediate treatment has been completed.
Have cancer that is at stage IIIB, IIIC, or IV, which means it is advanced and cannot be treated with radiation.
Be at least 18 years old.
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Have adequate biological function, including:
- Creatinine clearance (a measure of kidney function) of at least 30 ml/min.
- Neutrophils (a type of white blood cell) count of at least 1500/mm³.
- Platelets (cells that help with blood clotting) count of at least 100,000/mm³.
- Hemoglobin (a protein in red blood cells) level of at least 8 g/dL.
- Liver enzymes less than 3 times the upper limit of normal (ULN), except for patients with liver metastases, where it should be less than 5 times ULN.
- Total bilirubin (a substance made by the liver) level of 1.5 times ULN or less, except for patients with Gilbert's syndrome or liver metastases, where it should be less than 3 times ULN.
- Women who can become pregnant must have a negative pregnancy test within 14 days before starting the study treatment.
- Women who can become pregnant must agree to use effective birth control methods or remain abstinent during the study and for at least 6 months after the last dose of study drugs.
- Men with partners who can become pregnant must agree to use a condom or remain abstinent during the study and for at least 6 months after the last dose of study treatment.
- Be covered by national health insurance.

Who cannot join the trial?

6 criteria

Patients who have not been previously treated with immunotherapy or platinum-based chemotherapy cannot participate. Immunotherapy is a type of cancer treatment that helps your immune system fight cancer. Platinum-based chemotherapy uses drugs containing the metal platinum to kill cancer cells.
Patients with medical conditions other than Advanced MET exon 14 Mutated Non-Small Cell Lung Cancer are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to provide informed consent or understand the study requirements are excluded.
Patients who are pregnant or breastfeeding are not eligible to participate.
Patients with any other serious health conditions that could interfere with the study are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France

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Investigated drugs

Tepotinib is a medication being tested in this clinical trial for its effectiveness in treating a specific type of lung cancer known as MET exon 14 mutated non-small cell lung cancer (NSCLC). This medication works by targeting and blocking a protein that is involved in the growth and spread of cancer cells. By inhibiting this protein, tepotinib aims to slow down or stop the progression of the cancer, providing a potential treatment option for patients who have already received other forms of cancer therapy, such as immunotherapy or chemotherapy.

What is already known about the treatment

Tepotinib – Tepotinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with a specific genetic mutation known as MET exon 14 skipping. This medication works by blocking the activity of a protein called MET, which is involved in the growth and spread of cancer cells. By inhibiting this protein, tepotinib aims to slow down or stop the progression of cancer. It is classified as a targeted therapy, specifically a MET inhibitor, and is being compared to standard treatments to determine its efficacy in patients who have previously received immunotherapy or chemotherapy.

Investigated diseases

Advanced MET exon 14 Mutated Non-Small Cell Lung Cancer – This is a type of lung cancer characterized by mutations in the MET exon 14 gene. It primarily affects the epithelial cells in the lungs, leading to uncontrolled cell growth. The disease progresses as these mutated cells multiply, forming tumors that can invade nearby tissues. Over time, the cancer may spread to other parts of the body, a process known as metastasis. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. Symptoms often include persistent cough, shortness of breath, and chest pain as the disease advances.