A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)
This study is for people with advanced non-small cell lung cancer. It's testing new combinations of medicines like KEYTRUDA, favezelimab, quavonlimab, and Lenvatinib. The main goal is to see how much the cancer shrinks after treatment. Researchers will also check how long people live without their cancer getting worse, overall survival, and any side effects. This is a Phase 2 study, which means it's still in the earlier stages of testing new treatments to see if they are promising before larger studies are done. It aims to find better ways to treat this type of lung cancer.
At a glance
What is this study about?
This study is called KEYNOTE-495 and it's looking into new ways to treat advanced non-small cell lung cancer. This is a type of lung cancer that has spread from where it started. Doctors are always looking for better treatments to help people live longer and have a better quality of life.
In this study, researchers are testing several new combinations of medicines. One of the main drugs being used is KEYTRUDA, which is a type of immunotherapy. This kind of medicine helps your own immune system fight the cancer. They are combining KEYTRUDA with other drugs like favezelimab, quavonlimab, and Lenvatinib. The hope is that by combining these drugs, they might work even better together than they would on their own.
The main thing the doctors want to find out in this study is how well these drug combinations shrink the cancer. This is called the 'objective response rate'. They will also be carefully watching for any side effects and how these treatments affect how long people live or how long they live before their cancer gets worse. This is a Phase 2 study, which means it's an important step to see if these new combinations are promising enough to be tested in even larger studies in the future.
Key takeaways
- New drug combinations for advanced lung cancer.
- Includes immunotherapy (KEYTRUDA).
- Aims to shrink tumours and improve survival.
- Phase 2 study: early stage of testing.
- Close monitoring for effectiveness and side effects.
- Participation involves regular clinic visits and tests.
Who may be eligible?
This study is for adults generally aged 18 or older. It is open to both men and women.
To be considered for this study, you must have advanced non-small cell lung cancer that has spread to other parts of your body (Stage IV). Because this is an advanced type of study, there will be other specific medical checks to make sure your body can handle the treatments and that the study is right for you. These checks will be done by the study doctors.
There will also be some conditions that might mean you can't join, for example, if you have certain other serious health problems or if you've had specific treatments recently. The study team will review all your medical information carefully to see if you are a good fit.
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 advanced non-small cell lung cancer (Stage IV)?
- Are you generally feeling well enough to consider a new treatment?
- Are you able to attend regular clinic appointments for treatment and tests?
What does participation involve?
If you decide to take part in this study, you would receive the study medication (which includes KEYTRUDA and other drugs like favezelimab, quavonlimab, or Lenvatinib) as agreed with your doctor. This will involve regular visits to the clinic for treatments, usually given through a drip (infusion), and close monitoring.
Throughout the study, you would have appointments for various tests. These would include blood tests, physical examinations, and scans (like CT scans) to check how the treatment is working and to look for any side effects. These tests help the doctors understand if the cancer is shrinking and if the drugs are safe for you.
The exact number of visits and the total length of your participation would depend on how your body responds to the treatment. Treatment will continue as long as it is benefiting you and you are not experiencing significant side effects. After treatment finishes, there will be follow-up appointments to monitor your health over time.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What type of cancer is this study for?
It's for advanced non-small cell lung cancer (Stage IV).
What drugs are being tested?
The study is testing combinations of drugs like KEYTRUDA, favezelimab, quavonlimab, and Lenvatinib.
What does a 'Phase 2' study mean?
It means the study is in an earlier stage, checking if the new treatments are safe and show promise before larger studies are done.
What is the main goal of the study?
The main goal is to see how much the cancer shrinks after treatment (objective response rate).
Can I leave the study if I want to?
Yes, you can leave the study at any time, for any reason, without affecting your regular 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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