Not recruiting

Study of Osimertinib for Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Verified siteRegistered drugNo placebo

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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) that has specific changes in the EGFR gene. The treatment being tested is a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is taken as a tablet and works by blocking certain proteins that help cancer cells grow. The purpose of this study is to evaluate how effective osimertinib is in treating this type of lung cancer.

Participants in the study will receive osimertinib as their first treatment for NSCLC. The study will involve taking the medication regularly and attending scheduled visits for monitoring. During these visits, doctors will check how the cancer is responding to the treatment and monitor the overall health of the participants. Some participants may receive a placebo, which looks like the real medication but does not contain the active substance.

The study will also include additional research on biological samples to better understand how osimertinib works and to explore other potential effects of the treatment. This research may involve analyzing blood and tissue samples to look for changes in the cancer or in the body’s response to the treatment. The study aims to provide valuable information on the effectiveness and safety of osimertinib for patients with EGFR-mutated non-small cell lung cancer.

The research process

The trial runs in 6 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, the patient provides written informed consent, confirming understanding and agreement to participate.
Eligibility is confirmed based on criteria such as age, medical history, and specific genetic markers related to non-small cell lung cancer.
Step 2
Initial assessment
A comprehensive medical evaluation is conducted to establish a baseline for the patient's health status.
This includes imaging tests and laboratory analyses to document the extent of the disease and any brain metastases.
Step 3
Medication administration
The patient begins treatment with osimertinib, administered orally.
The dosage is either 40 mg or 80 mg, depending on the specific requirements of the treatment plan.
The medication is taken daily, with the duration of administration continuing as long as the patient benefits from the treatment.
Step 4
Regular monitoring
The patient's response to the treatment is regularly monitored through scheduled medical appointments.
These appointments include physical examinations, imaging tests, and laboratory tests to assess the effectiveness of the treatment and any side effects.
Step 5
Progress evaluation
The primary goal is to evaluate the objective response rate, which measures how well the cancer responds to the treatment.
Secondary evaluations include progression-free survival, duration of response, and overall survival.
Step 6
Completion of study
The study is estimated to conclude by August 31, 2025.
Upon completion, a final assessment is conducted to determine the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

9 criteria

You must provide a signed and dated, written informed consent. This means you agree to participate after understanding the study details.
You need to be older than 18 years.
You should have a confirmed diagnosis of **locally advanced or metastatic NSCLC**. This means your lung cancer has spread and cannot be treated with surgery or radiation to cure it. If you had treatment for non-spreading cancer before, a new tissue sample is needed.
You must have a confirmed **EGFR mutation** in specific parts of your genes, except for certain changes in one part called exon 20.
Your **ECOG status** should be between 0-2, which is a way to measure your ability to perform daily activities. You should also have a life expectancy of at least 12 weeks.
If you have brain metastases, which means cancer has spread to your brain, you can still participate if they are untreated but mild or moderately symptomatic. If they are treated and stable, you can also participate.
You need to have at least one cancer area that can be measured and has not been treated with radiation or used for a biopsy during the study screening.
If you are a female, you should use effective birth control, not be breastfeeding, and have a negative pregnancy test if you can have children. If you cannot have children, you need to show proof, like being post-menopausal or having had certain surgeries.
If you are a male, you must agree to use barrier contraception, like condoms.

Who cannot join the trial?

3 criteria

Patients who do not have **EGFR-mutated non-small cell lung cancer**. This is a specific type of lung cancer with a change in the **EGFR** gene.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Karolinska University Hospital
Verified
Solna, Sweden
Oslo Universitetssykehus HF
Verified
Oslo, Norway
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
Responsive
Vilnius, Lithuania

Trial locations

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Investigated drugs

Osimertinib is a medication used in this clinical trial as a first-line treatment for patients with non-small cell lung cancer that has specific mutations in the EGFR gene. It works by targeting and blocking the activity of the mutated EGFR proteins, which are responsible for the growth and spread of cancer cells. This helps to slow down or stop the progression of the cancer.

Osimertinib

What is already known about the treatment

Osimertinib – Osimertinib is administered orally in tablet form. It is currently approved and widely used in the treatment of certain types of lung cancer, specifically EGFR-mutated non-small cell lung cancer. The medication works by targeting and inhibiting the activity of the epidermal growth factor receptor (EGFR) with specific mutations, which are often responsible for the growth and spread of cancer cells. Osimertinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy that interferes with specific enzymes involved in cancer cell proliferation.

Investigated diseases

EGFR-mutated non-small cell lung cancer – This is a type of lung cancer characterized by mutations in the epidermal growth factor receptor (EGFR) gene. These mutations lead to uncontrolled cell growth and division, contributing to the development of tumors in the lungs. The disease typically progresses by spreading to other parts of the body, including the brain and bones. Patients may experience symptoms such as persistent cough, shortness of breath, and chest pain. The progression of the disease can vary, with some tumors growing slowly while others may spread more rapidly. Understanding the specific genetic mutations involved is crucial for determining the most effective treatment approach.