Open-label Phase 3 Study of MK-7684A (Coformulation of Vibostolimab with Pembrolizumab) in Combination with Concurrent Chemoradiotherapy followed by MK7684A Versus Concurrent Chemoradiotherapy followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III NSCLC (KEYVIBE-006)
This research study, called KEYVIBE-006, is exploring treatments for a type of lung cancer known as non-small cell lung cancer, specifically when it's advanced and can't be surgically removed. Participants will receive a combination of chemotherapy and radiotherapy. After that, they will either receive a new investigational medicine called MK-7684A (which combines two drugs, vibostolimab and pembrolizumab) or a standard treatment called durvalumab. The goal is to see if the new treatment combination is more effective or has different outcomes compared to the current standard care. This study is for adults aged 18 and over.
At a glance
What is this study about?
This study is focused on a specific type of lung cancer called non-small cell lung cancer (NSCLC). When this cancer is advanced and can't be taken out with an operation, doctors explore other treatment options. This research is trying to find the best way to help people in this situation.
In this study, everyone will first receive a combination of chemotherapy and radiotherapy. These are common treatments for cancer that aim to shrink tumours and kill cancer cells. After this initial treatment, participants will be put into one of two groups. One group will receive a newer combination of medicines, called MK-7684A. This is actually two drugs (vibostolimab and pembrolizumab) given together. The other group will receive a medicine called durvalumab, which is already a standard treatment for this type of cancer after chemotherapy and radiotherapy.
The main idea is to compare how well these two different follow-up treatments work. Researchers want to see if the new combination (MK-7684A) offers better results, fewer side effects, or a better quality of life compared to the standard treatment (durvalumab). By taking part, you could be helping doctors learn more about the best ways to treat this challenging cancer, potentially helping many people in the future.
Key takeaways
- Targets advanced non-small cell lung cancer that can't be surgically removed.
- Compares a new drug combination (MK-7684A) with a standard treatment (durvalumab).
- All participants receive initial chemotherapy and radiotherapy.
- Study is for adults aged 18 and over.
- Aims to find better treatment options for this type of lung cancer.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.
Because this is a specific type of lung cancer study, you would need to have been diagnosed with non-small cell lung cancer that is considered 'locally advanced,' meaning it has grown in the immediate area but isn't spread widely throughout your body, and it cannot be removed by surgery.
There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These checks ensure that the treatment won't cause unnecessary risks and that the study results will be meaningful.
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 non-small cell lung cancer?
- Has your doctor told you your cancer is 'locally advanced' and cannot be removed by surgery?
- Are you prepared for initial chemotherapy and radiotherapy?
- Are you able to attend regular hospital appointments for treatments and check-ups?
What does participation involve?
If you decide to take part in this study, you would first go through some initial medical checks. If eligible, you would start with a combination of chemotherapy and radiotherapy. This phase typically involves regular hospital visits for these treatments over several weeks.
After completing the chemotherapy and radiotherapy, your doctors will then decide which follow-up medicine you will receive – either MK-7684A or durvalumab. These are usually given as infusions, meaning the medicine is given directly into your bloodstream through a drip, typically over a set period of time at regular intervals. You would have regular appointments for these infusions and for check-ups to see how you are doing and to monitor for any side effects.
Taking part in a study like this usually involves multiple hospital visits over many months. This includes regular tests, scans, and discussions with the healthcare team to monitor your health and the progress of your treatment. The total duration of your participation could be quite long, potentially several years, including follow-up appointments.
Potential risks and benefits
Locations (11)
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- —UnverifiedCroatia
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- —UnverifiedFrance
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Common questions
What kind of lung cancer is this study for?
This study is for non-small cell lung cancer that is advanced in the local area and cannot be removed by surgery.
What are the main treatments I would receive?
You would first have chemotherapy and radiotherapy, followed by either the new investigational medicine MK-7684A or a standard treatment called durvalumab.
How old do I need to be to join?
You must be 18 years old or older to be considered for this study.
Will I know which treatment I'm getting?
In some studies, participants know which treatment they are receiving after the initial phase. The study team will explain how this works before you consent.
What is the new medicine MK-7684A?
MK-7684A is a combination of two medicines, vibostolimab and pembrolizumab, which are being tested together.
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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