A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in previously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (LEAP-008)
This study is exploring improved treatments for a type of lung cancer known as non-small cell lung cancer (NSCLC). This trial focuses on patients whose cancer has spread and has already been treated with standard chemotherapy and immunotherapy. We are comparing a new combination of two medicines, pembrolizumab and lenvatinib, against a commonly used chemotherapy drug called docetaxel. The main aim is to find out if the new combination can help people live longer and prevent the cancer from growing for a longer period. We also want to understand if these treatments are safe and how they affect a person's quality of life, including symptoms like cough or chest pain.
At a glance
What is this study about?
This study, called LEAP-008, is important because it's looking for better ways to treat a specific type of lung cancer. This is for people who have non-small cell lung cancer (NSCLC) that has spread (become metastatic) and has already been treated with two standard approaches: platinum-based chemotherapy and immunotherapy. When cancer has already been treated and still isn't fully controlled, doctors need more options to help patients.
In this study, some people will receive a combination of two drugs: pembrolizumab (also known as KEYTRUDA) and lenvatinib. Pembrolizumab is an immunotherapy that helps your body's immune system fight cancer, while lenvatinib is a targeted drug that helps stop cancer cells from growing. Other people in the study will receive docetaxel, which is a chemotherapy drug that has been used to treat lung cancer for a while.
We want to see if the combination of pembrolizumab and lenvatinib works better than docetaxel. Specifically, we'll be looking at how long people live (Overall Survival) and how long they live without their cancer getting worse (Progression-free Survival). We'll also be carefully checking for any side effects and how the treatments affect daily life and symptoms, like tiredness, pain, or breathing difficulties. This will help doctors understand which treatment approach might be best for patients in this situation.
Key takeaways
- Looks for new treatments for advanced lung cancer that has previously been treated.
- Compares two new drugs together against a standard chemotherapy.
- Focuses on how long people live and how well the treatment controls cancer.
- Also considers safety and quality of life for patients.
- Your doctor will discuss if this trial is right for you.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years of age or older, with non-small cell lung cancer. This cancer can be of different types, sometimes called squamous or non-squamous histology.
Crucially, your cancer must have spread to other parts of your body (metastatic), and you must have already received previous treatments. These prior treatments should include a type of chemotherapy called 'platinum doublet chemotherapy' and also 'immunotherapy'. Your cancer must also have shown signs of getting worse after these previous treatments.
A medical team will carefully review your health and medical history to make sure the study is a suitable and safe option for you. They will explain all the details and answer any questions you may have.
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 an adult aged 18 or over?
- Do you have non-small cell lung cancer that has spread?
- Have you already had both chemotherapy (platinum doublet) and immunotherapy for your cancer?
- Has your cancer started to progress or get worse after these previous treatments?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of three treatment groups. This means you have an equal chance of receiving the combination of pembrolizumab and lenvatinib, lenvatinib by itself, or the chemotherapy drug docetaxel. The study is 'open-label,' which means both you and your study doctor will know which treatment you are receiving.
You'll have regular visits to the clinic for your treatments, which will be given through an injection into a vein (infusion) or taken as tablets. During these visits, the study team will carry out health checks, blood tests, and scans to monitor your cancer and your general health. You'll also be asked to fill out questionnaires about how you are feeling and your quality of life.
The study will involve several months of treatment and monitoring, with ongoing follow-up visits even after treatment might stop, to see how you are doing in the long term. The exact total duration will be explained by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedPortugal
- —UnverifiedGermany
- —UnverifiedHungary
Common questions
What type of lung cancer is this study for?
This study is for advanced non-small cell lung cancer (NSCLC) that has spread and has already been treated.
What treatments are being tested?
We are comparing a combination of pembrolizumab and lenvatinib to docetaxel chemotherapy.
Will I know which treatment I'm getting?
Yes, in this study, both you and your doctor will know which treatment you are receiving.
What will the study mainly measure?
The main things we'll measure are how long people live and how long their cancer stays stable without getting worse.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your 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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