A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS) KEYNOTE-091
This study, called KEYNOTE-091, is testing a new treatment called Keytruda (pembrolizumab) for a common type of lung cancer called non-small cell lung cancer (NSCLC). This is for patients who have had surgery to remove their cancer and completed their standard treatments. The main goal is to see if Keytruda can prevent the cancer from returning for a longer time compared to a dummy treatment (placebo). Researchers are particularly interested in patients whose cancer cells show a specific marker called PD-L1. They will also look at how long people live and any side effects. Both men and women aged 18 and over can take part.
At a glance
What is this study about?
Imagine you've had surgery for lung cancer and have finished your usual treatments. This study is looking at whether an additional treatment, called Keytruda, can help reduce the chance of the cancer coming back. Keytruda is a type of medicine that helps your own immune system fight cancer cells.
The study wants to find out if patients who receive Keytruda stay cancer-free for longer than those who receive a placebo (a dummy drug with no active ingredients). This is especially important for patients whose cancer cells have a particular feature called PD-L1. They will also be closely monitoring how long patients live and whether the treatment causes any unwanted side effects.
This kind of study is called a 'Phase 3' trial, which means it's one of the final steps before a new treatment might become widely available. The information gathered will help doctors understand if Keytruda is a safe and effective way to help prevent lung cancer from returning in these patients.
Key takeaways
- This study evaluates Keytruda to prevent lung cancer recurrence after surgery.
- It's for early-stage non-small cell lung cancer patients, aged 18 and over.
- Compares Keytruda to a placebo to see if it extends the time patients stay cancer-free.
- Focuses on patients whose cancer has completed standard treatments.
- Close monitoring for effectiveness and side effects will be part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To take part in this study, you would generally need to be an adult, aged 18 or older. Both men and women can join.
You must have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC). Your cancer needs to be in an early stage (specifically Stage IB, II, or IIIA) and you must have had surgery to remove it, as well as completed any other standard treatments your doctor recommended.
There will be other medical checks to make sure this study is safe and right for you, but these are the main starting points for who might be able to participate.
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.
- Am I 18 years old or older?
- Have I been diagnosed with non-small cell lung cancer?
- Was my cancer Stage IB (with a tumour 4cm or larger), Stage II, or Stage IIIA?
- Have I had surgery to remove my lung cancer?
- Have I finished all my standard treatments (like chemotherapy or radiotherapy)?
- Am I generally well enough to participate in a clinical trial?
What does participation involve?
If you decide to join this study, you will likely be randomly assigned to receive either Keytruda or a placebo (a dummy treatment). This is done by chance, like flipping a coin, so neither you nor your doctor can choose. Both Keytruda and the placebo are given as a solution through a drip into your arm (infusion).
You will have regular visits to the clinic for these infusions, as well as for various tests and check-ups. These checks will help doctors monitor how you are doing, track your cancer, and keep an eye on any side effects. The total length of your participation, including follow-up after your treatment period, would be explained fully by the study team, but these types of studies often involve several years of monitoring.
Potential risks and benefits
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Common questions
What is Keytruda?
Keytruda is a medicine that helps your body's immune system recognize and fight cancer cells more effectively.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the active medicine fairly.
What does 'non-small cell lung cancer' mean?
It's the most common type of lung cancer. This study specifically focuses on certain early stages of this type of cancer.
What is PD-L1?
PD-L1 is a protein found on some cancer cells. If your cancer has a lot of it, it might mean Keytruda could be more effective.
Will I know if I'm getting Keytruda or the placebo?
No, this type of study is 'blinded,' meaning neither you nor your doctors will know which treatment you are receiving until after the study is complete, unless there's a medical reason to find out.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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