Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-Doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC
This research study is for people with early-stage non-small cell lung cancer. It's comparing different treatment approaches. Some participants will receive the usual chemotherapy. Others will get a combination of chemotherapy and new medicines called nivolumab and ipilimumab. These new medicines are a type of immunotherapy, which helps your body's immune system fight cancer. The main goal is to find out if these new combinations are better than chemotherapy alone at preventing the cancer from coming back or spreading, and if they lead to a complete disappearance of cancer cells after treatment. It also looks at how long people live and other important health outcomes.
At a glance
What is this study about?
This study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) when it's caught in its early stages. When lung cancer is found early, surgery is often a key part of treatment. After surgery, doctors sometimes recommend chemotherapy to try and kill any remaining cancer cells and help stop the cancer from coming back. This study is testing if adding new medicines to chemotherapy can be even more effective.
The new medicines being tested are nivolumab and ipilimumab. These are a type of drug called immunotherapy. Immunotherapy works differently from chemotherapy. Instead of directly killing cancer cells, it helps your body's own immune system recognise and fight the cancer more effectively. The study wants to see if combining these immunotherapies with standard chemotherapy is better than chemotherapy on its own.
The main things the researchers are looking for are whether these new treatments can prevent the cancer from returning or spreading further away (this is called 'event-free survival'), and if they can lead to a complete disappearance of cancer cells (called a 'pathological complete response'). They will also look at how long people live and other measures of how well the treatments work. This is a "Phase 3" study, which means it's a large study designed to confirm if these new treatments are truly better and safe enough to become standard care.
Key takeaways
- This study evaluates new ways to treat early-stage lung cancer.
- It compares standard chemotherapy with new immunotherapy combinations.
- The goal is to see if new treatments prevent cancer recurrence or spread.
- Participation involves receiving one of the study treatments and regular check-ups.
- It's a Phase 3 study, aiming to confirm treatment effectiveness and safety.
Who may be eligible?
This study is looking for adults, aged 18 and over, of any gender. To join the study, you must have been diagnosed with early-stage non-small cell lung cancer.
Your doctor will need to check your full medical history and some blood tests to make sure that the treatments in the study are likely to be safe and suitable for you. There might be some other specific health conditions or medications that could prevent you from taking part, but your doctor will go through all of that with you.
It's important to discuss with your doctor if you think you might be interested. They can fully assess if you meet all the requirements for this particular research study.
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?
- Have you been diagnosed with early-stage non-small cell lung cancer?
- Are you prepared to receive one of the study treatments which will be chosen at random?
- Are you able to attend regular appointments for treatment and check-ups?
What does participation involve?
If you join this study, you would be put into one of three groups by chance, like flipping a coin. One group will receive standard chemotherapy. The other groups will receive either nivolumab plus ipilimumab, or nivolumab plus platinum-doublet chemotherapy. The exact medicines you receive will be given as an infusion into your vein, likely at a hospital or clinic. You will have regular appointments and tests, including blood tests and scans, to check how you are responding to the treatment and to monitor for any side effects. The total duration of active treatment and follow-up will depend on your specific treatment plan and how you respond, but will involve a series of treatment cycles followed by regular check-ups over a longer period.
Potential risks and benefits
Locations (4)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedSpain
Common questions
What is 'early-stage non-small cell lung cancer'?
This means your lung cancer has been caught at an earlier point, before it has spread too far. Often, surgery is an option at this stage.
What is chemotherapy?
Chemotherapy uses strong medicines to kill fast-growing cancer cells in your body.
What are nivolumab and ipilimumab?
These are immunotherapy drugs. They work by helping your body's own immune system find and fight cancer cells.
What does 'Phase 3 trial' mean?
A Phase 3 trial is a large study that compares a new treatment with an existing standard treatment, to see if the new one is better and safe enough to be used more widely.
Will I know which treatment I'm getting?
No, this is an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.
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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