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

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) that has specific genetic changes called EGFR mutations and MET amplification. These changes can make the cancer more aggressive and harder to treat. The study is testing a combination of two medications: Osimertinib and Savolitinib. Osimertinib, also known by its code name AZD9291, is already used to treat certain types of lung cancer. Savolitinib, with the code name AZD6094, is being tested to see if it can help when used together with Osimertinib.

The purpose of this study is to see how effective the combination of these two drugs is in treating patients whose cancer has progressed after initial treatment with Osimertinib alone. Patients participating in the study will take these medications in the form of film-coated tablets, which are taken orally. The study will monitor how the cancer responds to the treatment over time, and researchers will collect data on the overall response rate, which means how well the cancer shrinks or disappears after treatment.

Participants will be closely observed throughout the study to ensure their safety and to gather information on any side effects they might experience. The study aims to provide valuable insights into whether adding Savolitinib to Osimertinib can offer a new treatment option for patients with this specific type of lung cancer. The trial is expected to continue until 2025, allowing researchers to gather comprehensive data on the effectiveness and safety of this treatment combination.

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 central testing to confirm specific genetic markers. This sample must be collected after progression on previous osimertinib therapy.
Step 2
Treatment initiation
The treatment involves taking two medications: osimertinib and savolitinib. Both are administered orally in the form of film-coated tablets.
The dosage for osimertinib is determined based on the specific needs of the patient, while savolitinib is administered at 300 mg twice daily (bid) or once daily (od), depending on the specific trial group.
Step 3
Ongoing treatment and monitoring
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as CT or MRI to measure tumor size and progression.
Blood tests are performed to monitor the levels of the medications and to check for any side effects. Vital signs, including blood pressure and heart rate, are also regularly checked.
Step 4
Evaluation of treatment response
The primary goal is to evaluate the overall response rate (ORR) to the treatment. This is assessed by the investigator using specific criteria.
Secondary evaluations include progression-free survival (PFS), overall survival (OS), and changes in quality of life as measured by specific questionnaires.
Step 5
Completion of study participation
The study is expected to continue until May 2025. Participation may end earlier if the treatment is not effective or if significant side effects occur.
Upon completion, a final assessment is conducted to evaluate the overall health status 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 adequate kidney function, which means a certain level of kidney health as shown by specific blood tests.
Must have adequate blood clotting ability, shown by specific blood tests, unless taking medication that affects these tests.
Patients with blood clots in veins can participate if they are stable on certain blood-thinning medications for at least 2 weeks.
Must have a performance status of 0 or 1, meaning they are fully active or have some symptoms but do not need to stay in bed, and have a life expectancy of at least 12 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 stopping the study drug.
Must have a confirmed diagnosis of a specific type of lung cancer with certain genetic changes that respond to a specific treatment.
Must have shown disease progression after treatment with a specific medication called osimertinib.
Must have specific genetic changes in the cancer, confirmed by certain tests on a tumor sample taken after progression on osimertinib.
Must have a tumor sample available for testing or be willing to provide a new sample that meets specific requirements.
Must have at least one tumor that can be measured accurately with a CT or MRI scan, and it should not have been treated with radiation or biopsied during the screening period.
Only patients who have received prior treatment with osimertinib in a metastatic setting are allowed.
Must have adequate blood cell counts, shown by specific blood tests, without recent blood transfusions.
Must have adequate liver function, shown by specific blood tests.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with **EGFRm+** and **MET+** **Non-Small Cell Lung Cancer**. This means the cancer cells have specific changes in their genes.
Patients whose cancer is not **locally advanced** or **metastatic**. This means the cancer has not spread to nearby tissues or other parts of the body.
Patients who have not previously been treated with a medication called **osimertinib**.
Patients who have not shown progression, meaning their cancer has not worsened after treatment with **osimertinib**.
Patients who do not have **MET amplified/overexpressed** cancer. This means the cancer cells do not have an increased number of copies or high levels of a specific protein.

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Verified sites

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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

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Investigated drugs

Osimertinib
is a medication used to treat certain types of non-small cell lung cancer. It works by targeting and blocking specific proteins that help cancer cells grow. In this trial, it is used to treat patients whose cancer has progressed after initial treatment with osimertinib.
Savolitinib
is a medication that targets and inhibits a protein called MET, which can be overactive in some cancer cells. By blocking this protein, savolitinib may help slow down or stop the growth of cancer. In this trial, it is combined with osimertinib to treat patients with advanced or metastatic non-small cell lung cancer.

What is already known about the treatment

Osimertinib
Osimertinib is administered orally in tablet form. It is currently approved for use in treating certain types of non-small cell lung cancer (NSCLC) and is well-documented in medical literature. The main therapeutic indication is for patients with locally advanced or metastatic NSCLC with specific genetic mutations. At the molecular level, osimertinib works by inhibiting the activity of the epidermal growth factor receptor (EGFR) with specific mutations, thereby blocking cancer cell growth. It is classified as a tyrosine kinase inhibitor.
Savolitinib
Savolitinib is also administered orally in tablet form. It is under investigation in clinical trials for its potential use in treating non-small cell lung cancer (NSCLC) with specific genetic alterations. The main therapeutic indication is for patients with locally advanced or metastatic NSCLC who have progressed after initial treatment. Savolitinib acts by inhibiting the MET receptor tyrosine kinase, which is involved in cancer cell proliferation 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 the most common type of lung cancer, accounting for about 85% of all cases. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, meaning it has spread to other parts of the body. In some cases, NSCLC may have specific genetic mutations, such as EGFR mutations and MET amplification, which can influence the progression and characteristics of the disease. These genetic changes can lead to resistance to certain treatments, necessitating alternative therapeutic strategies.