Study on the Effectiveness and Safety of Osimertinib for Patients with EGFR Mutation-Positive Stage II-IIIB Non-Small Cell Lung Cancer After Tumor Removal

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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). The study is specifically looking at patients who have a mutation in the Epidermal Growth Factor Receptor (EGFR), which is a protein that can affect the growth of cancer cells. The treatment being tested is a medication called osimertinib, also known by its code name AZD9291. Osimertinib is a type of drug known as a Tyrosine Kinase Inhibitor (TKI), which works by blocking certain proteins that help cancer cells grow.

The purpose of this study is to evaluate the effectiveness and safety of taking osimertinib for five years in patients who have had their lung cancer surgically removed. Some patients may have also received additional treatment called adjuvant chemotherapy, which is given after surgery to help eliminate any remaining cancer cells. The study will follow participants over a period of time to see how well they do without the cancer returning.

Participants in the study will take osimertinib in the form of film-coated tablets, which are taken by mouth. The study will monitor the participants’ health and any side effects they may experience while taking the medication. The goal is to see how many participants remain free of cancer over the course of five years. This information will help determine if osimertinib is a beneficial treatment option for patients with this specific type of lung cancer.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding the study’s procedures and agreeing to participate.

Eligibility is confirmed based on specific criteria, including age, diagnosis of non-small cell lung cancer, and complete surgical removal of the tumor.

2 medication administration

The medication osimertinib is administered orally. It is available in two dosages: 40 mg and 80 mg film-coated tablets.

The treatment duration is set for 5 years, with the aim of assessing the medication’s effectiveness and safety.

3 monitoring and assessments

Regular monitoring is conducted to evaluate the patient’s health and the medication’s impact.

Assessments focus on the proportion of participants who remain alive and free of disease at 3, 4, and 5 years.

4 completion of the study

The study is expected to conclude by April 2029.

Final evaluations will determine the long-term effectiveness and safety of osimertinib in treating non-small cell lung cancer.

Who Can Join the Study?

Provide informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
Be able to sign the informed consent form, which includes agreeing to follow the study’s rules and restrictions.
Sign and date a separate consent form if you agree to provide samples for optional genetic research.
Be male or female and at least 18 years old.
Have a confirmed diagnosis of primary Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer, with mostly non-squamous cells.
Have an MRI or CT scan of the brain before surgery, which are imaging tests to check the brain. If not done within 6 weeks before surgery, it must be done before joining the study.
Be classified after surgery as Stage II, IIIA, or IIIB based on the size and spread of the cancer, according to a specific staging system for lung cancer.
Have confirmation from a local lab that the tumor has specific EGFR mutations, which are changes in a gene related to cancer growth. These include common mutations like Ex19del and L858R, or uncommon ones like G719X, S768I, and L861Q, but not exon 20 insertions.
Have had complete surgical removal of the primary NSCLC, meaning all visible cancer was removed, and the edges of the removed tissue are free of cancer. This can be done through open surgery or a less invasive method called Video Associated Thoracic Surgery.

Who Cannot Join the Study?

Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate. Non-Small Cell Lung Cancer is a type of lung cancer that grows and spreads more slowly than small cell lung cancer.
Patients who have not been diagnosed with the specific genetic mutation called EGFRm are excluded. EGFRm refers to changes in a gene that can affect how cancer cells grow.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are unable to follow the study procedures or take the study medication as required are excluded.
Patients who are part of a vulnerable population, meaning they may have additional health or social challenges, are not eligible.

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
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Ospedale Vito Fazzi Lecce	Lecce	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
AORN San Giuseppe Moscati Avellino	Avellino	Italy
Azienda Socio Sanitaria Territoriale Della Valtellina E Dell Alto Lario	Sondrio	Italy
Hospital Universitario Virgen Macarena	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Alessandro Manzoni Hospital	Lecco	Italy
Ospedale P. Pederzoli Casa Di Cura Privata S.p.A.	Peschiera Del Garda	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Ilbrover Cyrwig Dnqcujvugynesenqs	L'hospitalet De Llobregat	Spain
Lu Mdsczlruh Szksvk	Palermo	Italy
Atzkehx Umh Igdwf Dc Rnksrn Exspvi	Reggio Emilia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	06.03.2023
Spain	Not recruiting	06.03.2023

Trial locations

Investigated drugs:

Osimertinib

Osimertinib is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as non-small cell lung carcinoma. This cancer must have a mutation in the epidermal growth factor receptor (EGFR). The trial aims to evaluate the effectiveness and safety of using osimertinib for five years after the complete surgical removal of the tumor. The goal is to see if osimertinib can help prevent the cancer from returning, with or without additional chemotherapy.

Investigated diseases:

Non-small cell lung cancer

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 all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.

Trial ID:

2023-508740-21-00

Protocol code:

D5162C00048

NCT ID:

NCT05526755

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Osimertinib for Patients with EGFR Mutation-Positive Stage II-IIIB Non-Small Cell Lung Cancer After Tumor Removal

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?