A randomized phase II study of Pembrolizumab (MK-3475) as maintainance therapy in patients with unresectable stage III non-small cell lung cancer treated with definitive chemo-radiotherapy (MP-LALC- Maintainance Pembrolizumab in Locally Advanced Lung Cancer).
This research study is for people with stage III non-small cell lung cancer that can't be surgically removed. These patients have already received chemotherapy and radiation therapy. The study is testing a drug called Pembrolizumab, also known as Keytruda, to see if taking it after their initial treatment helps them live longer. Researchers want to find out how long people live overall, how long they live without their cancer growing, and how many people respond to the treatment. This is a Phase II study, meaning it's still in the early stages of testing but is focused on seeing if the treatment works and is safe for this specific group of patients.
At a glance
What is this study about?
This study is looking into a new way to treat a specific type of lung cancer called non-small cell lung cancer. This particular study focuses on people whose cancer is at an advanced stage (stage III) and can't be removed by an operation. These patients have already gone through a standard treatment which includes both chemotherapy (strong medicines to kill cancer cells) and radiotherapy (using high-energy rays to kill cancer cells).
The main idea of this study is to see if a medicine called Pembrolizumab, also known as Keytruda, can be helpful after these initial treatments. Pembrolizumab is a type of immunotherapy, which means it works by helping your body's own immune system fight the cancer. The researchers want to find out if taking Pembrolizumab regularly after chemotherapy and radiotherapy helps people live longer.
They will be carefully watching several things: how long people live in total, how long they live without their cancer getting worse, and how many people see a positive effect from the treatment. This is a "Phase II" study, which means it's an important step in figuring out if this treatment is effective and safe enough to be tested more widely in the future. It's about exploring if this new approach can improve outcomes for patients with this type of lung cancer.
Key takeaways
- This study tests Pembrolizumab (Keytruda) for advanced lung cancer.
- It's for people who have already had chemotherapy and radiotherapy.
- The main goal is to see if it helps people live longer.
- It's a research study to understand how this new treatment works for this group.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To be able to join this study, participants need to meet certain requirements.
First, you must have been diagnosed with non-small cell lung cancer that is at stage III and cannot be removed with surgery. You also need to have recently completed a course of chemotherapy and radiotherapy as your main treatment for the cancer.
Participants must be 18 years old or older, and the study is open to both men and women. There will be other specific health checks to make sure the treatment is suitable and safe for you, which your doctor will discuss.
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?
- Do you have non-small cell lung cancer at stage III?
- Can your lung cancer not be removed by surgery?
- Have you recently finished chemotherapy and radiotherapy for your lung cancer?
What does participation involve?
If you decide to take part in this study, you would receive the study medication, Pembrolizumab (Keytruda), on a regular basis as an infusion (through a drip into a vein). You would need to attend regular hospital visits for these infusions and for check-ups. During these visits, the study team would monitor your health carefully, perform physical examinations, and likely take blood samples.
They would also use scans (like CT scans) to see how your cancer is responding to the treatment over time. You would be followed very closely throughout the study to make sure you are tolerating the treatment well and to track any changes in your health or your cancer. The total duration of your participation would depend on how long the treatment continues to be beneficial for you, and how long the researchers need to follow up on your progress.
Potential risks and benefits
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Common questions
What is Pembrolizumab (Keytruda)?
It's a type of immunotherapy that helps your body's immune system find and fight cancer cells.
What stage of lung cancer is this study for?
This study is for people with stage III non-small cell lung cancer that cannot be removed by surgery.
Do I need to have had other treatments first?
Yes, you must have already completed chemotherapy and radiotherapy for your lung cancer.
How will the doctors know if the treatment is working?
They will monitor you with regular check-ups, blood tests, and scans to see how your cancer responds.
Can I stop being part of the study once I've started?
Yes, you are free to leave the study at any time, and it won't affect your future 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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