A Randomized, Double-Blind, Phase 3 Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy as First Line Treatment for Participants with Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)
This research study is for people with advanced non-small cell lung cancer that has spread to other parts of the body. It's a 'Phase 3' study, meaning it's a large trial to see if a new treatment is better than existing ones. We are comparing two approaches: one involves two existing drugs (pembrolizumab, also known as KEYTRUDA, and chemotherapy) and the other uses a new combined drug (MK-7684A, which includes pembrolizumab and another drug called vibostolimab) along with chemotherapy. The main goal is to find out if the new combination helps people live longer and if it's safe. We’ll also look at how effective the treatment is, how it affects quality of life, and any side effects.
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 when it has spread to other parts of the body. This is often called 'advanced' or 'metastatic' lung cancer. Researchers are testing a new combination treatment against a standard treatment. They want to see if the new combination can help people live longer, improve their quality of life, and if it's safe to use.
The standard treatment for this type of lung cancer often includes a drug called pembrolizumab (also known as Keytruda) along with chemotherapy. Pembrolizumab works by helping your body's immune system fight cancer. In this study, the new treatment being tested is a combination of pembrolizumab and another drug called vibostolimab (together known as MK-7684A), given with chemotherapy.
This is a ‘Phase 3’ study, which is the final stage before a new treatment might become widely available. It involves a larger number of patients and carefully compares the new treatment to the existing one. Doctors will closely monitor how patients respond to treatment, how they feel, and any side effects they experience to understand if the new combination is a better option.
Key takeaways
- This study is for advanced non-small cell lung cancer.
- It compares a new treatment combination (MK-7684A + chemotherapy) to a standard one (Keytruda + chemotherapy).
- It's a large 'Phase 3' study to see which treatment is better and safer.
- The main aim is to see if the new treatment helps people live longer.
- Quality of life and side effects are also important parts of the study.
- Participation involves regular clinic visits for treatment, tests, and symptom checks.
Who may be eligible?
To join this study, you would generally need to be an adult, aged 18 or older. The study is open to both men and women.
You must have been diagnosed with non-small cell lung cancer that has spread to other parts of your body. This study is specifically for treatment that is given as a 'first-line' option, meaning it's the first main treatment you're receiving for your advanced lung cancer after diagnosis.
There might be other specific health requirements or conditions that would determine if this study is suitable for you. Your doctor will be able to check all the detailed criteria to see if you are a good fit for this particular research.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer that has spread?
- Is this your first main treatment for your advanced lung cancer?
- Are you willing to have regular hospital visits for treatment and check-ups?
- Are you comfortable with not knowing which treatment you will receive?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive either the new combined treatment (MK-7684A and chemotherapy) or the standard treatment (pembrolizumab and chemotherapy). Which treatment you receive would be decided randomly, like flipping a coin, and neither you nor your doctor would know which one you are getting (this is called ‘double-blind’). This helps to make sure the results are fair.
The treatments would be given through an infusion, which means they go directly into your bloodstream. You would have regular visits to the clinic for your treatments and to have check-ups, blood tests, and scans. These visits are to see how the treatment is working, to monitor your health, and to check for any side effects. You will also be asked to complete questionnaires about your quality of life, how you are feeling, and any symptoms you might have. The duration of your participation would depend on how your treatment is progressing and could continue for several months or even longer, with follow-up appointments after treatment finishes.
Potential risks and benefits
Locations (5)
- —Germany
- —Spain
- —Austria
- —France
- —Poland
Common questions
What is non-small cell lung cancer?
Non-small cell lung cancer is the most common type of lung cancer. 'Metastatic' means the cancer has spread from the lungs to other parts of the body.
What is 'Phase 3'?
Phase 3 is the final stage of testing a new treatment before it can be approved. It compares the new treatment to the best current treatment in a large group of people.
What is MK-7684A?
MK-7684A is a new combination of two existing drugs, pembrolizumab (Keytruda) and vibostolimab. It's being tested with chemotherapy.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the new combination or the standard treatment. This helps ensure fair results.
What are the main things the study wants to find out?
The study mainly wants to know if the new treatment helps people live longer and if it's safe. It also checks how treatments affect quality of life and cancer growth.
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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