KEYMAKER-U01 Master Study: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC)
This research is a 'Phase 2' study, which means it's testing if new drug combinations are safe and effective for people with advanced non-small cell lung cancer. The main aim is to see how many people's tumours shrink when treated with Pembrolizumab (Keytruda), either on its own or alongside other new drugs called rolistobart or MK-4830. Doctors will also check how long people live without their cancer getting worse, and keep a close eye on any side effects. This particular part of the study focuses on patients who haven't had treatment for their advanced cancer before and whose cancer shows a specific marker (PD-L1 positive). It's hoped these new combinations could offer better treatment options.
At a glance
What is this study about?
This study, called KEYMAKER-U01, is looking into new ways to treat advanced non-small cell lung cancer. This type of cancer is called 'advanced' when it has spread. The study is particularly interested in treatments that involve Pembrolizumab, which you might know as Keytruda. This is a medicine that helps your body’s own immune system fight the cancer.
In this specific part of the study, called Substudy 2, researchers are testing Pembrolizumab in combination with other new experimental medicines, like rolistobart or MK-4830. They want to see if these combinations work better than Pembrolizumab alone. They're focusing on people who haven't had treatment for their advanced lung cancer yet and whose cancer cells have a particular marker called PD-L1. This marker can sometimes help predict if Pembrolizumab will work well.
The main goal is to find out how many people respond to the treatment, meaning their tumours shrink or stop growing. They will also be carefully monitoring for how long people live without the cancer getting worse, and tracking any side effects to make sure the treatments are safe. By testing these new combinations, doctors hope to find more effective and gentler ways to treat non-small cell lung cancer, ultimately improving the lives of patients.
Key takeaways
- This study is testing new treatments for advanced non-small cell lung cancer.
- It combines Pembrolizumab (Keytruda) with other new experimental drugs.
- The focus is on patients who haven't had treatment for advanced cancer before and whose cancer is 'PD-L1 positive'.
- Doctors will check how well the drugs shrink tumours and for any side effects.
- Taking part means regular hospital visits for treatment and health checks.
- You can stop participating at any time.
Who may be eligible?
To join this study, you would generally need to be an adult, aged 18 years or older. Both men and women are welcome to take part.
Specifically, this particular part of the study is for people who have advanced non-small cell lung cancer. This means the cancer has spread beyond its original location. It's also for those who haven't received any treatment for their advanced lung cancer yet.
Your doctors will also look at specific tests of your cancer cells to see if they have a certain marker called PD-L1. This is important because the study is designed for people whose cancer is 'PD-L1 positive'. There will also be other medical checks to make sure the study treatment is safe for you, such as looking at your general health and other medical conditions.
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 advanced non-small cell lung cancer?
- Have you not had previous treatment for your advanced lung cancer?
- Has your doctor told you your cancer is 'PD-L1 positive'?
- Are you generally well enough for a clinical trial?
What does participation involve?
If you decide to take part in this study, you'll be assigned to receive one of the new drug combinations, which will include Pembrolizumab. The new drugs are given as an infusion, which means they are delivered directly into your bloodstream, usually through a drip.
You will have regular hospital visits for these treatments and for important health checks. These checks will include blood tests, physical examinations, and scans (like CT scans) to see how your cancer is responding and to look for any side effects. These visits will continue for a period, and you’ll also have follow-up visits after your treatment finishes to monitor your long-term health. The exact number of visits and the total duration will depend on which treatment you receive and how your body responds.
Potential risks and benefits
Locations (4)
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Common questions
What is Pembrolizumab (Keytruda)?
Pembrolizumab is a type of medicine that helps your body's own immune system fight cancer cells. It's often called immunotherapy.
What does 'non-small cell lung cancer' mean?
This is the most common type of lung cancer. 'Non-small cell' refers to how the cancer cells look under a microscope.
What is a 'Phase 2' study?
A Phase 2 study is a stage of clinical research where doctors test if a new treatment is safe and effective in a larger group of people, after initial safety checks. They also look at side effects.
What does 'PD-L1 positive' mean?
PD-L1 is a protein found on some cancer cells. If your cancer is 'PD-L1 positive', it means this protein is present, and it can sometimes mean your cancer might respond well to immunotherapy like Pembrolizumab.
Will I definitely get one of the new drugs?
Yes, in this specific study, participants will receive Pembrolizumab either on its own or combined with another new investigational drug.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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