Azienda Ospedaliero Universitaria Parma
Responsive
Parma, Italy
Not recruiting
Study Comparing Savolitinib and Osimertinib with Chemotherapy for Advanced Non-Small Cell Lung Cancer in Patients with EGFR Mutation and MET Overexpression
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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 the treatment of Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study is comparing the effectiveness of a combination of two medications, savolitinib and osimertinib, against a standard treatment known as platinum-based doublet chemotherapy. Savolitinib, also known by its code name AZD6094, is a medication that targets specific proteins in cancer cells. Osimertinib, sometimes referred to as AZD9291, is a drug that targets mutations in the epidermal growth factor receptor (EGFR), which are often found in NSCLC. The purpose of the study is to determine how well the combination of savolitinib and osimertinib works compared to chemotherapy in patients with NSCLC who have specific genetic changes and have previously been treated with osimertinib.
Participants in the study will be randomly assigned to receive either the combination of savolitinib and osimertinib or the chemotherapy treatment. The study will monitor the participants over a period to see how the cancer responds to the treatments. The researchers will look at how long the participants live without the cancer getting worse, which is known as progression-free survival. They will also assess overall survival, which is the length of time participants live after starting the study. The study will also evaluate the safety and side effects of the treatments, as well as how the treatments affect symptoms like shortness of breath, cough, and chest pain.
This trial is open-label, meaning both the participants and the researchers know which treatment is being given. The study will continue until 2027, and it aims to provide valuable information on the best treatment options for patients with advanced or metastatic NSCLC who have specific genetic changes and have progressed after previous treatment with osimertinib.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- You must provide a signed and dated written document called an Informed Consent Form (ICF) before any study-related procedures or tests.
- You should have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
- You must be at least 18 years old (19 years old in South Korea) when you sign the informed consent. People of all genders can participate.
- You need to have a confirmed diagnosis of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that cannot be cured with current treatments.
- You must have at least one specific change in the EGFR gene, such as exon19 deletion, L858R mutation, or T790M.
- You should have shown disease progression on your most recent treatment with a drug called osimertinib.
- You need to provide a sample of your tumor tissue, which is preserved in a special way called FFPE.
- Your tumor must show MET overexpression or amplification after progression on osimertinib treatment. This means the MET gene is more active or present in higher amounts than normal.
- You must have a disease that can be measured using a standard method called RECIST 1.1.
- Your blood, liver, kidney, and heart functions, as well as your blood clotting ability, must be at acceptable levels.
Who cannot join the trial?
5 criteria
- Patients who do not have Non-Small Cell Lung Cancer cannot participate. This is a type of lung cancer.
- Patients who do not have a mutation in the EGFR gene cannot participate. This gene is related to cell growth.
- Patients who do not have MET-overexpressed or amplified cancer cannot participate. This means the MET gene is not overly active or increased in number.
- Patients who have not progressed on treatment with osimertinib cannot participate. Osimertinib is a medication used to treat certain types of lung cancer.
- Patients who are not in a locally advanced or metastatic stage of cancer cannot participate. This means the cancer has not spread to nearby tissues or other parts of the body.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Istituto Europeo Di Oncologia S.r.l.
ResponsiveMilan, ItalyIstituto Oncologico Veneto
ResponsivePadua, Italy
Trial locations
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Investigated drugs
Savolitinib
is a medication being studied for its potential to treat certain types of lung cancer. It works by targeting and inhibiting specific proteins that are involved in the growth and spread of cancer cells. In this trial, savolitinib is being tested in combination with another medication to see if it can help improve outcomes for patients with advanced lung cancer.
Osimertinib
is a medication used to treat non-small cell lung cancer that has specific genetic mutations. It works by blocking the activity of proteins that promote cancer cell growth. In this study, osimertinib is used in combination with savolitinib to evaluate if the combination is more effective than standard chemotherapy in patients whose cancer has progressed after initial treatment with osimertinib.
Platinum-Based Doublet Chemotherapy
is a standard treatment for advanced lung cancer. It involves using two chemotherapy drugs, one of which is a platinum-containing compound, to kill cancer cells or stop them from growing. This type of chemotherapy is being used as a comparison in the trial to determine if the combination of savolitinib and osimertinib offers better results for patients.
What is already known about the treatment
Savolitinib
Savolitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) that has specific genetic mutations. It is being evaluated in combination with another medication, osimertinib, to see if it can improve outcomes for patients whose cancer has progressed despite previous treatment. Savolitinib works by targeting and inhibiting a protein called MET, which is involved in cancer cell growth and survival. It is classified as a tyrosine kinase inhibitor, a type of drug that blocks signals needed for tumors to grow.
Osimertinib
Osimertinib is an oral medication that is already approved for use in treating certain types of non-small cell lung cancer (NSCLC) with specific genetic mutations. It is being studied in combination with savolitinib to assess its effectiveness in patients whose cancer has progressed. Osimertinib works by targeting and inhibiting the epidermal growth factor receptor (EGFR) mutation, which is often present in NSCLC. It is classified as a tyrosine kinase inhibitor, helping to block the growth and spread of cancer cells.
Investigated diseases
Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often progresses slowly compared to small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease advances, it may lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511169-12-00Protocol codeD5087C00001Estimated enrolment327 patientsSponsorAstraZeneca AB
sourced from the EU Clinical Trials Register and site verification
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