A Master Protocol of a Phase II, Open-label, Multicenter, Global Platform Study to Evaluate the Safety and Efficacy of Immunotherapy With or Without Other Anticancer Drugs in Participants with Unresectable Stage III Non-small Cell Lung Cancer Planning to Undergo Concurrent Chemoradiotherapy (AQUARIUS)
This study, called AQUARIUS, looks at a new treatment approach for people with stage 3 non-small cell lung cancer that cannot be treated with surgery. Standard treatment usually involves chemotherapy given alongside radiotherapy (chemoradiotherapy). In this trial, doctors are testing whether adding a new immunotherapy drug called rilvegostomig works safely alongside standard treatments. Immunotherapy helps the body's natural immune system recognise and attack cancer cells. Other medicines may also be used to help manage side effects or improve how well the treatment works. The main goal of the trial is to find out if this drug combination is safe, well-tolerated, and able to stop the cancer from growing or spreading for longer. Adults aged 18 and over who are planning to start chemoradiotherapy may be able to take part.
At a glance
What is this study about?
Lung cancer is one of the most common cancers in the UK. Non-small cell lung cancer is the most frequent type. In stage 3, the cancer has spread into nearby tissues or lymph nodes within the chest, meaning surgery is usually not an option. The standard approach is often chemoradiotherapy, which combines chemotherapy drugs with radiotherapy to destroy cancer cells.
While current treatments can be helpful, doctors are looking for ways to improve outcomes and keep the cancer away for longer. This study is testing an experimental immunotherapy drug known as rilvegostomig. Immunotherapy is a type of cancer treatment that trains your own immune system to spot cancer cells and fight them off.
By adding this immunotherapy to standard chemotherapy drugs (such as carboplatin, cisplatin, paclitaxel, or pemetrexed) and radiotherapy, researchers hope to see better results. They want to learn how safe the combination is, what side effects it might cause, and whether it helps shrink tumours or delay cancer growth more effectively than current standard care.
Key takeaways
- The AQUARIUS study tests a new immunotherapy drug called rilvegostomig for stage 3 lung cancer.
- It is for adults whose cancer cannot be removed with surgery.
- The new medicine is given alongside standard chemotherapy and radiotherapy.
- The main aim is to check safety and see if the treatment keeps cancer from growing.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 and over who have been diagnosed with stage 3 non-small cell lung cancer. To be considered, your cancer must be 'unresectable', which means doctors have decided it cannot safely be removed using surgery.
You must also be fit enough and planning to start standard concurrent chemoradiotherapy, which means receiving chemotherapy and radiotherapy around the same time.
Not everyone will be able to join. For example, if your cancer has spread to distant parts of your body (stage 4), or if you have other serious medical conditions that make the treatment unsafe, this study may not be right for you. Your cancer care team can look at your medical records and scans to check your suitability.
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 3 non-small cell lung cancer.
- My doctor has told me my tumour cannot be removed by surgery.
- I am preparing to start chemotherapy and radiotherapy together.
- I am well enough to attend regular hospital visits for treatment and monitoring.
What does participation involve?
Taking part begins with a screening period where the study team checks your overall health using blood tests, scans, and physical exams to ensure the trial is safe for you. If you join, you will receive standard chemotherapy and radiotherapy alongside the study medicine. These drugs are usually given through a drip into a vein (an infusion) at the hospital. You will attend regular clinic visits where doctors will monitor your health, check for side effects, and take blood samples to measure drug levels in your body. Regular imaging scans (like CT or PET scans) will check how your tumour is responding. You will continue treatment and follow-up checks for several months or years, depending on how your cancer responds.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What does 'unresectable' mean?
It means the tumour cannot be safely or completely removed with an operation, often because of its size or position near vital organs.
How is the trial drug given?
The study medicines, including rilvegostomig and chemotherapy, are given as an infusion through a small tube into your vein at the hospital.
Will I still receive standard cancer treatment?
Yes. The study combines the new treatment with standard chemotherapy and radiotherapy, so you will still get standard anti-cancer care.
Do I have to pay to take part?
No. In the UK, clinical trial treatments and tests are provided free of charge, and some trials help cover travel expenses.
What happens if I decide to stop?
You can leave the study at any time without giving a reason. Your doctors will simply discuss other standard treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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