Study on the Safety and Effectiveness of Osimertinib and Datopotamab Deruxtecan for Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer

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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 a specific change in the EGFR gene. This change is called a mutation, and it can make the cancer grow. The study is looking at how well a treatment works for people with this kind of lung cancer. The treatment involves using a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is a type of drug that targets the EGFR mutation to help stop the cancer from growing. The study will also test osimertinib in combination with another drug called datopotamab deruxtecan, which is given as an infusion into a vein.

The purpose of the study is to see if the combination of osimertinib and datopotamab deruxtecan works better than osimertinib alone in treating this type of lung cancer. Participants in the study will be randomly assigned to receive either the combination treatment or osimertinib by itself. The study will monitor how the cancer responds to the treatments over time. Participants will receive regular check-ups and assessments to track their progress and any changes in their condition.

The study will continue for several years to gather enough information about the effectiveness and safety of the treatments. The goal is to find out if the combination of these medications can provide better outcomes for people with advanced or metastatic NSCLC that has the EGFR mutation. This research could help improve treatment options for patients with this type of lung cancer in the future.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of lung cancer, and genetic mutations.

A sample of tumor tissue is required to confirm the presence of specific genetic mutations.

2 randomization

Participants are randomly assigned to one of two groups: one receiving osimertinib alone, and the other receiving a combination of osimertinib and datopotamab deruxtecan.

3 treatment administration

For those receiving osimertinib alone, the medication is taken orally in the form of film-coated tablets, with a dosage of either 80 mg or 40 mg, as prescribed by the study protocol.

Participants in the combination group receive osimertinib orally and datopotamab deruxtecan intravenously as a solution for infusion.

4 monitoring and assessments

Regular monitoring is conducted to assess the progression of the disease and the effectiveness of the treatment.

Assessments include imaging tests to measure tumor size and check for any new lesions.

5 end of treatment

The treatment continues until there is evidence of disease progression or unacceptable side effects occur.

Participants are followed up to evaluate overall survival and progression-free survival.

Who Can Join the Study?

  • The participant must be at least 18 years old. If the participant is from Japan, they must be at least 20 years old.
  • The participant must have a type of lung cancer called nonsquamous non-small cell lung cancer (NSCLC), which has been confirmed through specific medical tests.
  • The lung cancer must be at an advanced stage, specifically Stage IIIB, IIIC, or Stage IV, or it must have come back after treatment. This means the cancer cannot be cured with surgery or a combination of chemotherapy and radiation at the time of joining the study.
  • The participant must not have received certain treatments before, specifically EGFR TKIs or other treatments for advanced lung cancer.
  • The participant’s tumor must have one of the two common EGFR mutations that respond well to a specific type of treatment. These mutations are called Ex19del or L858R. The tumor can have these mutations alone or with other EGFR mutations.
  • The participant must provide a sample of their tumor tissue, which has not been stained, from a previous test. This sample is needed to confirm the presence of the EGFR mutation.
  • The participant must have at least one tumor area that has not been treated with radiation before. This area must be measurable and meet specific size requirements using a CT or MRI scan. The longest part of the tumor must be at least 10 mm, except for lymph nodes, which must be at least 15 mm in the shortest part.

Who Cannot Join the Study?

  • Patients who do not have a specific type of lung cancer called EGFR mutation-positive, locally advanced or metastatic non-squamous non-small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Lungenfachklinik Immenhausen Germany
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Istituto Oncologico Veneto Padua Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Centrum Pulmonologii I Torakochirurgii W Bystrej Wilkowice Poland
Hospital Universitario Clínico San Cecilio Granada Spain
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Kliniken der Stadt Koeln gGmbH Cologne Germany
Muenchen Klinik gGmbH Munich Germany
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Institut de Cancérologie de l’Ouest Saint-Herblain France
Awdtxaq Okgesanwceu Uyibypsvwgjbc Pmaef Parma Italy
Awrqugfuay Psjlelgc Hpozaish Dm Mukoetzww Marseille France
Nisaplda Ilauhfzv Omgwpyikk Iiq Mqnqm Sekrydanisnwfesworievcnixzyc Iseyvwtu Burvyphg Cracow Poland
Hfxkjpsn Ujxkbkfgmjwjl dk A Cbeixf A Coruna Galicia Spain
Hhlmrfts Uloyzrzbbshutf Srkmbjzdjl &doqdwc Hpyhexb dk Hctvatnjsyd STRASBOURG, Alsace France
Ilciyyaq Cganf Paris France

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

Trial status

Country Status Recruitment Start
France France
Recruiting
10.01.2025
Germany Germany
Recruiting
10.01.2025
Italy Italy
Recruiting
10.01.2025
Poland Poland
Recruiting
10.01.2025
Spain Spain
Recruiting
10.01.2025

Trial locations

Osimertinib is a medication used to treat certain types of non-small cell lung cancer (NSCLC) that have specific mutations in the epidermal growth factor receptor (EGFR). It works by blocking the activity of the EGFR, which can help slow or stop the growth of cancer cells.

Datopotamab Deruxtecan (Dato-DXd) is an investigational drug being studied for its potential to treat cancer. It is designed to deliver chemotherapy directly to cancer cells, which may help to kill the cancer cells while minimizing damage to normal cells. In this trial, it is being tested in combination with osimertinib to see if it can improve treatment outcomes for patients with EGFR mutation-positive NSCLC.

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. A specific mutation in the epidermal growth factor receptor (EGFR) can drive the progression of this cancer, influencing its behavior and response to certain treatments.

Trial ID:
2023-509883-89-00
Protocol code:
D516NC00001
NCT ID:
NCT06350097
Trial Phase:
Therapeutic confirmatory (Phase III)

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