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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

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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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

9 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy

Trial locations

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Investigated drugs

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.

Osimertinib

What is already known about the treatment

Osimertinib – Osimertinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer, particularly in patients with specific genetic mutations. The main therapeutic indication for osimertinib is non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. At the molecular level, osimertinib works by inhibiting the activity of the EGFR, which is often overactive in certain cancer cells, leading to their growth and division. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

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 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.