Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study
This study is investigating people with a specific type of lung cancer called EGFR-positive non-small cell lung cancer. Many people with advanced lung cancer might need radiotherapy to help with symptoms or to treat new, small areas where the cancer has grown. This often happens while they are already taking a targeted drug called osimertinib (Tagrisso). The main aim is to see if it's safe to continue taking osimertinib during radiotherapy, and if it helps the treatment work better. Researchers will also look at how this affects a person's quality of life. Currently, there isn't much clear guidance on whether to pause the drug during radiotherapy, so this study hopes to provide important information for patients and doctors.
At a glance
What is this study about?
When someone has advanced lung cancer, especially a type called Non-Small Cell Lung Cancer (NSCLC) with an EGFR gene change, they might be taking a tablet called osimertinib, also known by its brand name Tagrisso. Sometimes, even while on this drug, small areas of cancer might grow, or a person might develop symptoms that need treatment. This is where radiotherapy can come in – it uses powerful X-rays to shrink tumours and ease symptoms.
A question doctors and patients often face is whether to keep taking osimertinib during radiotherapy or to pause it. We know that pausing treatment might allow the cancer to grow in other areas not being targeted by radiotherapy. However, there's not much clear information about whether it's safe or effective to use both treatments at the same time.
This study aims to find answers to these important questions. It will look closely at the safety of continuing osimertinib while having radiotherapy, by checking for any serious side effects. It will also assess how well the treatment works when both are used together, and importantly, how this combination affects a person's daily life and overall well-being. The findings will help doctors make better decisions with their patients in the future.
Key takeaways
- The study investigates combining osimertinib (Tagrisso) with radiotherapy.
- It's for people with a specific type of EGFR-positive lung cancer.
- Researchers will check for safety, effectiveness, and impact on quality of life.
- Participation involves ongoing monitoring and questionnaires.
- The goal is to provide clear guidance for patients and doctors in the future.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) with an EGFR gene change. You should either already be taking osimertinib (Tagrisso) or be planned to start it as part of your regular treatment. You also need to have a medical reason for radiotherapy, such as for symptom control, or because a few small areas of your cancer have started to grow.
Your general health and ability to carry out daily activities, often called 'performance status', will be assessed to make sure you are well enough. You should also be expected to live for at least 12 more weeks. If you are a woman who could become pregnant, you would need to use effective contraception and have a negative pregnancy test, or confirm you are past menopause.
It's important to discuss all your medical conditions and current treatments with the study team, as certain other health issues or medications might mean this study isn't right for you. The study aims to include a wide range of patients who fit these criteria, so if you think you might be eligible, it's a good idea to speak to your doctor.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have EGFR-positive Non-Small Cell Lung Cancer?
- Are you currently taking or planning to start osimertinib (Tagrisso)?
- Do you have a medical reason for radiotherapy?
- Are you generally well enough for daily activities? (ECOG performance status 0-2)
What does participation involve?
If you decide to take part, you'll continue taking your osimertinib as prescribed. You'll also receive radiotherapy for the areas of your cancer that need treating. The study team will closely monitor you throughout this period.
This will involve regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to treatment and to check for any side effects. You will also be asked to complete questionnaires about your quality of life, which helps understand how you are feeling day-to-day. The total duration of your participation will depend on your individual treatment plan and how long you continue to benefit from the study treatment, with regular follow-up appointments.
Potential risks and benefits
Locations (1)
- LMU Klinikum der Universität MünchenVerified postcodeMünchen, Germany
Common questions
What is EGFR-positive NSCLC?
It's a type of lung cancer where the cancer cells have a specific change in their genes (called EGFR) that can make them respond to certain targeted drugs like osimertinib.
What is osimertinib (Tagrisso)?
It's a tablet-based drug used to treat EGFR-positive lung cancer by blocking the signals that help cancer cells grow and spread.
What is radiotherapy?
Radiotherapy uses high-energy X-rays to destroy cancer cells or prevent them from growing, often used to shrink tumours or relieve symptoms.
Why is this study important?
It's important because it will give doctors clearer information on whether it's safe to continue osimertinib while having radiotherapy, which is currently a question without a clear answer.
Will I get a placebo (dummy drug) in this study?
No, this study doesn't use a placebo. You will continue to receive osimertinib and radiotherapy if you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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