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Study on Osimertinib and Savolitinib for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer After Previous Osimertinib Treatment

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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) that is locally advanced or has spread to other parts of the body. The study is specifically looking at patients whose cancer has certain genetic changes, called EGFR mutations and MET amplifications. These changes can affect how the cancer grows and responds to treatment. The trial is testing a combination of two medications: osimertinib and savolitinib. Osimertinib is already used to treat this type of lung cancer, and the study aims to see if adding savolitinib can help patients who have not responded well to osimertinib alone.

The purpose of the study is to determine how effective the combination of osimertinib and savolitinib is in treating this specific type of lung cancer. Participants in the study will take these medications in the form of film-coated tablets, which are taken by mouth. The study will monitor how the cancer responds to the treatment over time, as well as any changes in the size of the tumors. The trial will also collect information on the safety of the treatment and any side effects that may occur.

Throughout the study, participants will undergo regular check-ups and tests to assess their health and the progress of their cancer. These tests may include imaging scans like MRI or CT scans to measure the size of the tumors. The study will also track the levels of the medications in the blood to understand how they are processed by the body. The trial is expected to continue until May 2025, with the goal of providing valuable information on the potential benefits of combining osimertinib and savolitinib for patients with this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A tumor sample is required for testing to confirm specific genetic markers (EGFRm+ and MET+).
Step 2
Treatment initiation
The treatment involves taking two medications: savolitinib and osimertinib. Both are administered orally in the form of film-coated tablets.
Savolitinib is taken at a dose of 300 mg once daily.
Osimertinib is available in two dosages: 40 mg and 80 mg. The specific dosage will be determined by the healthcare provider.
Step 3
Ongoing monitoring
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as CT or MRI scans to measure tumor size.
Blood tests are performed to monitor the levels of the medications and their effects on the body.
Step 4
Evaluation of response
The primary goal is to evaluate the overall response rate to the treatment. This is assessed by measuring changes in tumor size and progression.
Secondary evaluations include progression-free survival, overall survival, and changes in quality of life.
Step 5
Completion of study
The study is estimated to conclude by May 28, 2025. At the end of the study, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

15 criteria

Patients must be at least 18 years old (20 years old in Japan). All genders can participate.
Must have good kidney function, which means a certain level of creatinine in the blood or a specific rate of kidney filtration.
Must have normal blood clotting ability, unless taking medication that affects this.
Patients with a blood clot in a vein or tumor can join if they are stable on blood-thinning medication for at least 2 weeks.
Must have a good general health status, with no worsening in the last 2 weeks, and expected to live at least 12 more weeks.
Females must use effective birth control, not be breastfeeding, and have a negative pregnancy test if they can have children, or show they cannot have children.
Males with a female partner who can have children should use barrier contraception during the study and for 6 months after.
Must have a specific type of lung cancer with a known mutation that responds to a certain treatment, and it cannot be cured with surgery or other treatments.
Must have shown disease progression on a specific first-line treatment called osimertinib.
Must have a specific genetic change called MET-amplification, confirmed by a test on a tumor sample after progression on osimertinib.
Must have a tumor sample available for testing or be willing to provide one, meeting specific requirements.
Must have at least one tumor that can be measured accurately, not treated with radiation before, and not biopsied during the screening period.
Only allowed to have had one prior treatment with osimertinib in a metastatic setting.
Must have good blood health, including a certain level of white blood cells, hemoglobin, and platelets without recent transfusions.
Must have good liver function, with specific levels of liver enzymes and bilirubin.

Who cannot join the trial?

7 criteria

Patients who do not have a specific type of lung cancer called EGFRm+ and MET+ Non Small Cell Lung Cancer cannot participate. This means the cancer must have certain genetic changes.
Patients who have not previously been treated with a medication called osimertinib cannot participate. This is a specific treatment for certain lung cancers.
Patients who have not shown progression, meaning their cancer has not worsened, after using osimertinib cannot participate.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Patients who are not part of the specified clinical trial group cannot participate. This means the study is looking for specific characteristics in participants.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be eligible. This refers to groups who might need special protection in research.

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Centre Hospitalier Universitaire De Rennes
Rennes, France

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Investigated drugs

Osimertinib
is a medication used to treat certain types of non-small cell lung cancer (NSCLC). It works by targeting and blocking specific proteins that help cancer cells grow. In this trial, it is used in combination with another medication to see if it can help patients who have already been treated with osimertinib but whose cancer has progressed.
Savolitinib
is a medication that targets and blocks a protein called MET, which can be overactive in some cancer cells. By inhibiting this protein, savolitinib may help slow down or stop the growth of cancer cells. In this trial, it is combined with osimertinib to evaluate its effectiveness in treating patients with advanced or metastatic non-small cell lung cancer.

What is already known about the treatment

Osimertinib
This medication is administered orally in tablet form. It is currently approved for use in treating certain types of lung cancer and is well-documented in medical literature. Osimertinib is primarily used for treating non-small cell lung cancer (NSCLC) with specific genetic mutations. It works by inhibiting the activity of the epidermal growth factor receptor (EGFR) at the molecular level, which helps to slow down or stop the growth of cancer cells. It is classified as a tyrosine kinase inhibitor.
Savolitinib
This medication is also taken orally in tablet form. It is under investigation in clinical trials and is not yet widely approved for general medical use. Savolitinib is being studied for its potential to treat non-small cell lung cancer (NSCLC) with specific genetic alterations. It functions by targeting and inhibiting the MET receptor tyrosine kinase, which can contribute to cancer cell growth and survival. It is classified as a MET inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slower growth compared to small cell lung cancer, and it often spreads to other parts of the body. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, indicating it has spread to distant organs. Mutations in genes such as EGFR and MET can drive the progression of NSCLC, influencing how the cancer grows and responds to certain treatments.