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Study of Cabozantinib for Patients with Non-Small Cell Lung Cancer and MET Deregulation

Verified siteRegistered drugNo 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 patients who have a change in a gene called MET, which can affect how the cancer grows. The treatment being tested in this study is a medication called Cabozantinib, which is taken as a tablet. Cabozantinib is also known by its code name XL-184. The purpose of the study is to see how effective Cabozantinib is in treating patients with this specific type of lung cancer.

Participants in the study will take Cabozantinib tablets by mouth. The study will monitor how the cancer responds to the treatment over time. Some patients may receive different doses of the medication, such as 20 mg, 40 mg, or 60 mg tablets, depending on the study's requirements. The study will also include a group of patients who will not receive the active medication but a placebo instead. The study aims to understand how well the treatment works and how long it can help control the cancer.

The trial will also look at other important outcomes, such as how long patients live without the cancer getting worse, overall survival, and how well the disease is controlled. Additionally, researchers will explore certain markers in blood and tissue samples to learn more about the disease and the effects of the treatment. The study is expected to continue until 2025, providing valuable information on the use of Cabozantinib in treating non-small cell lung cancer with MET changes.

The research process

The trial runs in 6 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 provided with detailed information about the trial, including its purpose and what to expect. You will be required to give your written informed consent, confirming your understanding and willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history and a series of tests to ensure you meet the study criteria. These tests may involve blood samples and imaging studies.
Step 3
Treatment phase
During the treatment phase, you will receive the medication cabozantinib in the form of film-coated tablets. The dosage will be determined by the study team and may include 20 mg, 40 mg, or 60 mg tablets. The medication is taken orally, and the frequency and duration will be specified by the study protocol.
Step 4
Regular monitoring
Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes scheduled visits for physical examinations, blood tests, and imaging studies. The study team will monitor your health and any side effects you may experience.
Step 5
End of treatment
At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response to the medication. This will involve similar tests and evaluations as the initial assessment.
Step 6
Follow-up
After completing the treatment, follow-up visits will be scheduled 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 data for the study.

Who can join the trial?

11 criteria

Diagnosis of non-small-cell lung cancer (NSCLC) at stage III B or stage IV.
Tissue samples must be available for MET analysis. If no tissue is available, a blood test showing MET mutation is acceptable.
Presence of specific MET mutations or MET amplification in the cancer cells.
Measurable disease according to specific medical criteria.
At least one previous treatment with standard therapy, such as chemotherapy or immunotherapy.
Good general health status, defined as performance status 0-1 on a specific scale.
Age 18 years or older.
If there is a possibility of having children, use effective birth control methods during the study and for at least 4 months after completing therapy.
Good blood and organ function, as shown by specific laboratory tests.
Willingness to follow the study procedures.
Provide written informed consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients with other types of cancer besides non-small cell lung cancer cannot participate.
Patients who have a different genetic mutation than MET amplification or MET exon 14 skipping mutation are not eligible.
Patients who are not within the specified age range cannot join the study.
Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

Cabozantinib is a medication used in this clinical trial to treat patients with a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC). This medication works by targeting specific proteins in cancer cells, which can help slow down or stop the growth of the cancer. In this study, Cabozantinib is being tested to see how effective it is for patients whose cancer has certain genetic changes, specifically involving a protein called MET. The goal is to see if Cabozantinib can help reduce the size of the cancer or stop it from growing.

Cabozantinib

What is already known about the treatment

Cabozantinib – Cabozantinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) with specific genetic changes, such as MET amplification or MET exon 14 skipping mutation. The main therapeutic use of Cabozantinib is to target and inhibit the activity of certain proteins that promote cancer cell growth and survival. At the molecular level, it works by blocking the MET receptor tyrosine kinase, which is involved in the pathways that lead to tumor growth and spread. Cabozantinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues. Over time, these cancerous cells may enter the bloodstream or lymphatic system, leading to metastasis. The progression of the disease can vary depending on the subtype and individual patient factors. Symptoms often include persistent cough, chest pain, and difficulty breathing.