IMMUNOTIME « EVALUATION OF THE EFFECT OF TIME OF ADMINISTRATION ON THE ACTIVITY ON FIRST LINE OF PEMBROLIZUMAB IN ASSOCIATION WITH CARBOPLATIN PEMETREXED IN METASTATIC NON-SQUAMOUS LUNG CANCER. A RANDOMISED MULTICENTER PHASE III TRIAL»
This study, called IMMUNOTIME, focuses on adults in the UK with a type of advanced lung cancer. It's a Phase III trial, meaning it's a large study to confirm if a treatment is effective. Participants will receive a standard combination of chemotherapy (Pemetrexed and Carboplatin) along with an immunotherapy drug, Pembrolizumab (also known as Keytruda). The main question is whether giving Pembrolizumab at a specific time of day changes how well it works. Researchers will track patients for at least a year to see if the timing affects survival, how long the cancer is kept under control, and quality of life. This research aims to understand if adjusting treatment schedules can lead to better outcomes for patients.
At a glance
What is this study about?
The IMMUNOTIME study is trying to find the best way to give an important treatment for a specific type of advanced lung cancer. This particular cancer is called 'non-squamous non-small cell lung cancer' (NSCLC) that has spread to other parts of the body (stage IV). The study is focusing on adults aged 18 and over.
The treatment being studied is a combination of chemotherapy drugs – Pemetrexed and Carboplatin – given alongside an immunotherapy drug called Pembrolizumab, also known by its brand name Keytruda. Immunotherapy works by helping your body's own immune system fight the cancer. What makes this study unique is that it's looking specifically at *when* Pembrolizumab is given. Researchers want to know if giving this drug at a certain time of day can make it work better.
This is a 'Phase III' trial, which means it's a large study designed to thoroughly test if the new idea (different timing of the drug) is effective and safe before it becomes a standard treatment. By comparing outcomes in groups of patients who receive the treatment at different times, the researchers hope to improve how this cancer is treated, potentially leading to longer and better lives for patients.
Key takeaways
- It's for adults with advanced non-squamous non-small cell lung cancer.
- It tests if different timing of Pembrolizumab (Keytruda) improves treatment.
- You'll get standard chemotherapy plus Pembrolizumab.
- Study involves regular treatments, scans, and questionnaires.
- It's a large study aiming to find better ways to treat this cancer.
- Participation lasts at least one year.
Who may be eligible?
This study is looking for adult patients who have been diagnosed with a specific type of lung cancer. This cancer is called 'non-squamous non-small cell lung cancer' and it must be at an advanced stage (stage IV), meaning it has spread beyond the original site.
If you are 18 years old or older, you might be able to join. Both men and women are welcome to participate. The medical team will check other specific health details to make sure the study is a good fit for you and that it's safe for you to take part.
- Are you 18 years old or older?
- Do you have advanced (stage IV) non-squamous non-small cell lung cancer?
- Are you able to travel to study appointments?
- Are you happy to fill out questionnaires about your health and sleep?
- Are you comfortable with being assigned to a treatment time by chance?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to one of two groups. Both groups will receive the same medications: Pemetrexed, Carboplatin, and Pembrolizumab (Keytruda). The only difference will be the time of day you receive the Pembrolizumab infusion. The chemotherapy drugs are given as an infusion (into a vein).
You'll have regular hospital visits for your treatments and to have check-ups, blood tests, and scans (like CT scans, PET scans, or MRI scans) to see how you're responding to the treatment. These scans will happen at specific times, for example, around 6 weeks after starting and then regularly over the first year. You will also be asked to fill in questionnaires about your quality of life, sleep, and daily routines at different points throughout the year. The total duration of your participation in the study will last for at least one year.
Potential risks and benefits
Locations (1)
- —France
Common questions
What kind of lung cancer is this study for?
This study is for adults with advanced (stage IV) non-squamous non-small cell lung cancer.
What drugs will I be given?
You will receive a combination of chemotherapy drugs called Pemetrexed and Carboplatin, along with an immunotherapy drug called Pembrolizumab (Keytruda).
What is the main thing the study is trying to find out?
The study wants to see if the time of day that Pembrolizumab is given affects how well the treatment works to control the cancer and how long patients live.
How long will I be in the study?
You will be followed and monitored for at least one year as part of the study.
Will I get to choose when I receive my medication?
No, you will be randomly assigned to a group, which means the time of day for your Pembrolizumab will be decided by chance by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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