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 study about?

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.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of two groups: one receiving a combination of savolitinib and osimertinib, and the other receiving platinum-based chemotherapy.

The study aims to compare the effectiveness of these treatments in individuals with a specific type of lung cancer.

2 treatment with savolitinib and osimertinib

Participants in this group will take osimertinib orally. The dosage will be either 40 mg or 80 mg, depending on the specific requirements of the study.

In addition, participants will take savolitinib in the form of film-coated tablets. The exact dosage and frequency will be determined by the study protocol.

3 platinum-based chemotherapy

Participants in this group will receive chemotherapy drugs such as pemetrexed, cisplatin, and carboplatin through intravenous infusion.

The specific drugs and their combinations will be administered according to the study’s schedule, which will be explained in detail by the medical team.

4 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

This will include medical examinations, imaging tests, and laboratory tests as required by the study protocol.

5 completion of the study

The study is expected to continue until April 2027. Participants will be informed about the duration of their involvement and any follow-up procedures.

Upon completion, the results will be analyzed to determine the effectiveness of the treatments.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centre Hospitalier Universitaire Rouen Rouen France
Institut Jules Bordet Anderlecht Belgium
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Hospital Foch Suresnes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
Asklepios Klinik Gauting GmbH Gauting Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
San Camillo Forlanini Hospital Rome Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
HELIOS Klinikum Emil von Behring GmbH Berlin Germany
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Vitaz Sint-Niklaas Belgium
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
University General Hospital Of Heraklion Heraklion Greece
AORN San Giuseppe Moscati Avellino Avellino Italy
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Henry Dunant Hospital Center Athens Greece
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Munster Germany
Bioclinic S.A. Thessaloniki Greece
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
General University Hospital Of Larissa Larissa Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Jessa Ziekenhuis Hasselt Belgium
General University Hospital Of Patras Patras Greece
Centre Hospitalier Universitaire De Nantes Nantes France
Muenchen Klinik gGmbH Munich Germany
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A. Peschiera Del Garda Italy
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centre Hospitalier Universitaire De Rennes Rennes France
Hospital Alvaro Cunqueiro Vigo Spain
CHU Helora La Louviere Belgium
Hopital Beaujon Clichy France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Uniklinikum Salzburg Salzburg Austria
Waldburg-Zeil Akutkliniken GmbH & Co. KG Wangen Germany
Awufbwj Ocfsdrwxipf Uedcvoxvogvlz Pedbf Parma Italy
Ityrph Iabruvce Fyejbvhaeeuie Oscnauqrntm Rome Italy
Hqprbcjq Ucfvozzrzctph Dx Bzfprjx Badajoz Spain
Pfex Tafun Hglotuns Urnobdkmxxgn Sabadell Spain
Tbjvreamwh Cfzalq Hrxzotci Thessaloniki Greece
Lkuax Gfhqlqe Hwdbohmj Oj Ahyuta Athens Greece
Iajuyayf Rrkxilmtj Pmm Le Sxwcmd Dju Tpjmfn Dkzx Afgvmxk Iask Spyjfx Meldola Italy
Ahinacibzx Pbmsbeog Hfzbcdok Dk Mxtpmgxoj Marseille France
Ghsoks Uertblnonc Fntsskbep Frankfurt Germany
Uckwmadsfs Ob Azafbwf Edegem Belgium
Ienkqqpr Cdsygx Ddekxmkfyyggqxtcq L'hospitalet De Llobregat Spain
Chazmr Hwctrktvggt Ryhjozzh Dbnijgyiwumfrx Angers France
Hckdfmst Uegxyasfrcgsc Hylgteqt Tgqyk y Puszpc Ivzsdnvk Cnnbqf dtovindyeywoyubfg (eqhp Badalona Spain
Hpzudkmr Veyu dpvmrzsa Barcelona Spain
Hxnhymcu Uinjcwxwprotq do A Cvasrl A Coruna Galicia Spain
Ucznoaliyv Gvpjkxe Hdiqvetm Asylkha Athens Greece
Hfntzlda Uxmzrkibdperxm Srjmefgydr &xwcdzm Hiqbxkt dl Hwudodzrkqz STRASBOURG, Alsace France
Iieoxftp Cdqap Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
28.03.2023
Belgium Belgium
Not recruiting
28.03.2023
Bulgaria Bulgaria
Not recruiting
28.03.2023
France France
Not recruiting
28.03.2023
Germany Germany
Not recruiting
28.03.2023
Greece Greece
Not recruiting
28.03.2023
Italy Italy
Not recruiting
28.03.2023
Poland Poland
Not recruiting
28.03.2023
Spain Spain
Not recruiting
28.03.2023

Trial locations

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.

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 ID:
2024-511169-12-00
Protocol code:
D5087C00001
NCT ID:
NCT05261399
Trial Phase:
Therapeutic confirmatory (Phase III)

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