RADICAL-IO: thRee cycles of immunotherApy without raDical therapy In mediCALly InOperable stage I non-small cell lung cancer
Stage I non-small cell lung cancer is usually treated with surgery or intense radiotherapy to remove or destroy the tumour. However, some people have other health conditions that make these treatments unsafe. This trial, called RADICAL-IO, is testing a different approach. The study looks at an immunotherapy drug called cemiplimab (brand name Libtayo). Immunotherapy works by helping your body's own immune system find and attack cancer cells. In this trial, participants receive three doses of the drug through a drip. Doctors want to find out how well this treatment stops the cancer from growing or coming back, and how safe it is. They will monitor side effects closely, particularly lung inflammation, to see if this short course of immunotherapy can offer a gentler, effective alternative for people who cannot have standard surgery.
At a glance
What is this study about?
When lung cancer is found early at Stage I, the usual goal is to cure it using surgery to remove the tumour, or using high-dose radiotherapy. Unfortunately, these treatments can put heavy stress on the body. For people living with other medical conditions, such as severe heart or lung problems, surgery or strong radiotherapy may be considered too risky. Doctors describe this as being 'medically inoperable'. Currently, there are limited gentle treatment options for people in this situation.
The RADICAL-IO trial is exploring whether an immunotherapy medicine called cemiplimab (also known as Libtayo) could be an effective alternative. Rather than attacking the tumour directly with radiation or chemicals, cemiplimab works by releasing the 'brakes' on your immune system. This allows your natural defences to recognise and fight the cancer cells.
In this study, patients receive three treatments of cemiplimab. Researchers will follow participants closely to see how long the treatment keeps the cancer from growing or returning. They will also measure how well the tumour shrinks and check how the treatment affects overall health.
This study matters because it could provide a much-needed, kinder option for patients who cannot have standard treatments. If successful, a short course of immunotherapy might help people live longer, healthier lives without the need for high-risk surgery.
Key takeaways
- Tests whether three doses of the immunotherapy drug cemiplimab can treat early lung cancer.
- Designed for people with Stage I non-small cell lung cancer who cannot safely have surgery.
- Treatment is given as a drip into a vein once every few weeks for three cycles.
- Aims to offer a gentler alternative to surgery or high-dose radiotherapy.
- Taking part is voluntary, and you are closely monitored for side effects throughout.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with Stage I non-small cell lung cancer. It is open to people of all genders.
To take part, your medical team must have decided that standard surgery or intensive radiotherapy is not safe for you. This is usually because of other ongoing health issues, such as heart disease, breathing difficulties, or general frailty.
You will need to have health checks before joining to make sure your liver, kidneys, and bone marrow are working well enough for immunotherapy. People with certain serious autoimmune conditions, or those who need high doses of steroids, may not be able to join because immunotherapy can make these conditions worse.
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.
- I am aged 18 or older.
- I have been diagnosed with Stage I non-small cell lung cancer.
- My doctor has advised that surgery or radical radiotherapy is not safe for me.
- I am well enough to attend hospital visits for treatment and scans.
- I do not have an uncontrolled autoimmune disease that prevents me having immunotherapy.
What does participation involve?
If you take part, you will receive cemiplimab through a drip into a vein (an intravenous infusion) once every few weeks, for a total of three treatments. Each infusion takes about 30 minutes, usually given in a hospital day unit.
Before each treatment, you will have routine checks such as blood tests, physical examinations, and questions about how you are feeling. You will also have regular CT scans to see how your tumour is responding to the medicine.
After you finish the three doses, you will enter a follow-up stage. You will have regular clinic visits and scans over several months or years so doctors can track your health and check for any delayed side effects. Your total time in the trial will depend on how you respond, but the active treatment period is relatively short.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is immunotherapy?
Immunotherapy is a type of cancer treatment that boosts your body's natural defences. It helps your immune system spot and destroy cancer cells.
Why can't I just have surgery?
Surgery can put great strain on the heart and lungs. If you have other long-term health problems, your doctors may feel an operation carries too high a risk.
How is the medicine given?
It is given as a liquid through a small tube into a vein in your arm (a drip). It takes around 30 minutes per visit.
What happens if my cancer gets worse during the trial?
Your doctors will scan you regularly. If the cancer grows or returns, your team will discuss alternative treatments, such as targeted radiation or other medicines.
Do I have to pay to take part in this trial?
No. In the UK, trial medicines and any extra study-related tests are provided free of charge through the NHS or the study sponsor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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