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Study on the Safety of Osimertinib with Radiation for Patients with Stage IV EGFR-Mutation Positive Non-Small Cell Lung Cancer

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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 the safety and effectiveness of continuing treatment with osimertinib, also known by its code name AZD9291, during radiation therapy. The study involves patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. The trial includes three groups of patients: those receiving radiation for cancer that has spread to bones, organs, or soft tissues; those with cancer that has spread to the brain; and those with cancer in the lungs.

The purpose of the study is to assess the safety of continuing osimertinib treatment while patients undergo radiation therapy. The study will monitor for any side effects that may occur during and after the combination of these treatments. Patients will take osimertinib in the form of film-coated tablets, and the study will observe how well patients tolerate the treatment and how it affects their cancer.

Throughout the study, patients will receive regular check-ups to monitor their health and the progress of their cancer. The study aims to understand how well the combination of osimertinib and radiation therapy works in controlling the cancer and improving patients' quality of life. The trial will also look at how long patients live without their cancer getting worse and how long they live overall. The study is expected to continue until the end of 2026.

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. This is a necessary step before any study-specific procedures can begin.
The patient must be willing and able to comply with the study protocol, which includes attending hospital visits for treatment and scheduled follow-up examinations.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes a negative COVID-19 test if required, confirmation of age (18 years or older), and a histological confirmation of non-small cell lung cancer (NSCLC).
The patient's ongoing or planned treatment with osimertinib is verified. This medication is used for tumors with specific mutations and is administered as TAGRISSO 80 mg film-coated tablets taken orally.
Step 3
Radiotherapy planning
The patient undergoes planning for radiotherapy, which is indicated for one or more lesions. This could be for symptom control, oligoprogressive metastasis, or disease control.
Radiotherapy may target bone, solid organ, or soft-tissue lesions. Brain metastases should be less than 3 cm, and lung lesions should be no more than 5 cm.
Step 4
Treatment phase
During the treatment phase, the patient continues taking osimertinib while receiving radiotherapy. The safety of this combination is closely monitored.
The primary focus is on assessing any adverse events, particularly those affecting the lungs or heart, and differentiating between drug-induced and radiation-induced effects.
Step 5
Follow-up and monitoring
After the treatment phase, the patient attends follow-up visits to monitor their health and the effectiveness of the treatment.
Progression-free survival, time to treatment failure, local tumor control, and overall survival are evaluated. Quality of life is also assessed using a specific questionnaire.
Step 6
Study completion
The study is estimated to conclude by December 31, 2026. The patient's participation continues until the study's end or until they meet criteria for withdrawal.

Who can join the trial?

11 criteria

Provide written informed consent before any study-specific procedures.
Be willing and able to follow the study rules, including hospital visits and follow-up exams.
Have a negative COVID-19 test within one week before starting radiation therapy, if needed due to local COVID-19 conditions.
Be at least 18 years old when entering the study.
Have a confirmed diagnosis of **NSCLC** (a type of lung cancer).
Be currently receiving or planning to receive **osimertinib** treatment, which is a medication used for certain types of lung cancer.
Need radiation therapy for one or more cancer areas, such as for symptom control or disease management. This can include bone, organ, or soft-tissue areas. Brain metastases should be smaller than 3 cm, and lung lesions should be no more than 5 cm.
Have an **ECOG performance status** of 0-2, which is a scale that measures how well you can perform daily activities.
Have a life expectancy of at least 12 weeks.
Female participants should use effective birth control, have a negative pregnancy test, and not be breastfeeding if they can have children. They must also meet certain criteria to be considered unable to have children, such as being post-menopausal or having had certain surgeries.
Male participants who are sexually active with women who can have children should use effective birth control. Men who cannot produce sperm do not need to use contraception.

Who cannot join the trial?

7 criteria

Patients who do not have stage IV **EGFR-mutation positive NSCLC**. This is a type of lung cancer with a specific genetic change.
Patients who are not receiving **irradiation**. This is a treatment using high-energy rays to target cancer.
Patients with brain metastases larger than 3 cm. **Metastases** are cancer cells that have spread from the original tumor to other parts of the body.
Patients with lung lesions larger than 5 cm. **Lesions** are abnormal areas of tissue.
Patients who are not in the age range specified for the study.
Patients who are not able to continue taking **osimertinib**. This is a medication used to treat certain types of lung cancer.
Patients who are not able to undergo both osimertinib treatment and irradiation at the same time.

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Goethe University Frankfurt
Verified
Frankfurt, Germany
Justus-Liebig-Universitaet Giessen
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Giessen, Germany

Trial locations

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Investigated drugs

Osimertinib
is a medication used in this study to treat certain types of lung cancer. It works by targeting specific proteins in cancer cells, helping to slow down or stop their growth. In this trial, the safety of continuing osimertinib treatment during radiation therapy is being assessed.
Radiation Therapy
is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this study, radiation therapy is used alongside osimertinib to see if it can safely and effectively treat cancer that has spread or is progressing in specific areas.

Osimertinib

What is already known about the treatment

Osimertinib – Osimertinib is administered orally in tablet form and is currently being studied for its safety and effectiveness when used alongside radiation therapy. It is primarily used to treat patients with stage IV non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. The medication works by targeting and inhibiting the activity of the mutated EGFR protein, which is involved in the growth and spread of cancer cells. Osimertinib is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. In stage IV, the cancer has spread beyond the lungs to other parts of the body, such as bones, brain, or other organs. Patients with EGFR-mutation positive NSCLC have a specific genetic mutation that can influence the growth of cancer cells. The disease progresses as the cancer cells continue to grow and spread, potentially leading to metastases in various body parts. Treatment often involves targeted therapies, but the disease can still progress despite these interventions.