Study of 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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
Hospital Universitario Virgen De La Victoria	Malaga	Spain
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Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	19.09.2019
Spain	Not recruiting	19.09.2019

Trial locations

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.

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.

Trial ID:

2024-512564-58-00

Protocol code:

SAVANNAH/D5084C0007

NCT ID:

NCT03778229

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?