A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Nonsmall Cell Lung Cancer (LA NSCLC)
This study is for people with a type of lung cancer that has grown into nearby areas but hasn't spread to other parts of the body, and who haven't been treated for it before. It's a 'Phase 3' study, meaning it's comparing new treatments, or new combinations of existing treatments, against standard care. Researchers want to see if combining nivolumab (a drug often used in cancer treatment) with chemotherapy and radiotherapy, followed by nivolumab alone or with another drug called ipilimumab, works better than a standard treatment with durvalumab. The main goal is to find out if these new approaches can stop the cancer from getting worse for a longer time, and also to check how long people live and what side effects they might experience. This helps doctors figure out the most effective options for patients.
At a glance
What is this study about?
This study is all about finding better ways to treat a specific type of lung cancer. It's for people who have 'locally advanced non-small cell lung cancer' (LA NSCLC), which means the cancer has grown into nearby areas but hasn't spread to distant parts of the body. Importantly, participants in this study would not have received any treatment for this cancer yet.
The study is comparing different treatment plans. One group of patients will receive a standard treatment that involves chemotherapy and radiotherapy, followed by a drug called durvalumab. Other groups will receive chemotherapy and radiotherapy, followed by nivolumab, either on its own or in combination with another drug called ipilimumab. All these drugs are involved in boosting the body's own immune system to fight cancer.
The main goal is to see which of these treatments best stops the cancer from growing or getting worse for the longest period. They will also be looking at how long people live, the rate at which tumours shrink, and also tracking any side effects to understand how well the treatments are tolerated. This helps doctors understand which treatment plans are most effective and safest for patients with this type of lung cancer.
Key takeaways
- Targets early, untreated, locally advanced non-small cell lung cancer.
- Compares standard treatment versus new drug combinations.
- Aims to find treatments that delay cancer growth.
- Checks for how long people live and potential side effects.
- Involves drugs like nivolumab, ipilimumab, and durvalumab.
- Patients receive chemotherapy, radiotherapy, then maintenance drugs.
Who may be eligible?
To join this study, you must have a specific type of lung cancer called 'locally advanced non-small cell lung cancer' that hasn't been treated yet. This means the cancer has grown into nearby areas but hasn't spread further throughout the body.
Participants must be at least 18 years old. Both men and women are welcome to take part in this research.
The study will also check other health factors to make sure it's safe for you to take part and that the results will be clear. Your doctor will be able to tell you if you meet all the necessary requirements.
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.
- Do you have locally advanced non-small cell lung cancer?
- Have you not had any prior treatment for this lung cancer?
- Are you 18 years old or older?
- Are you able to travel to the study clinic for appointments?
- Are you generally well enough to undergo cancer treatment?
What does participation involve?
Taking part in this study would involve a combination of treatments. You would first receive chemotherapy and radiotherapy, which are common cancer treatments. After this, you would receive maintenance treatment with one of the study drugs – either durvalumab, nivolumab on its own, or nivolumab combined with ipilimumab. The specific drugs you receive will be decided randomly, like flipping a coin.
Throughout the study, you would have regular appointments for check-ups, blood tests, and scans (like CT scans) to monitor your health and how the treatment is affecting the cancer. Doctors will also ask about any side effects you might be experiencing. The exact number of visits and the total length of your participation would depend on how your cancer responds to treatment, but these studies often involve regular monitoring over several months or even a few years.
Potential risks and benefits
Locations (11)
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedIreland
- —UnverifiedSweden
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedPoland
- —UnverifiedGreece
Common questions
What kind of lung cancer is this study for?
This study is for locally advanced non-small cell lung cancer that hasn't been treated before.
Are the treatments new or already used?
Some drugs are already used in cancer treatment, but this study looks at new ways to combine them or compare them against existing standard treatments.
What is the main goal of the study?
The main goal is to see which treatment plan best stops the cancer from growing or getting worse for the longest time.
Will I know which treatment I'm getting?
You will be assigned to a treatment group randomly, but the study is 'open label,' meaning you and your doctors will generally know which treatment you are receiving once assigned.
Can I stop being part of the study if I want to?
Yes, you can choose to leave the study at any time without it affecting your usual medical care.
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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