A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
This study, called LIBRA, is exploring new ways to treat non-small cell lung cancer that has spread or is advanced. Researchers are testing several new combinations of existing and experimental drugs to see how safe they are and how well people tolerate them. They will also look at how these medicines work in the body, checking things like how much medicine ends up in the bloodstream and how the body's immune system reacts to them. Most importantly, the study aims to find out if these new drug combinations can help shrink tumours or stop the cancer from growing. This is a Phase II study, meaning it's an earlier stage of research focused on safety and finding out if a treatment shows promise before larger studies are done.
At a glance
What is this study about?
This research study, known as LIBRA, is designed to investigate new treatment options for people with non-small cell lung cancer that is advanced or has spread to other parts of the body. We call this 'locally advanced' or 'metastatic' cancer. The study is a "Phase II" trial, which means it's an important early step. It helps doctors understand if new treatments are safe enough for patients and if they show enough promise to be studied further in larger groups of people.
The main goals of this study are to carefully check the safety of several new drug combinations. This includes looking at any side effects people might experience, both mild and more serious ones. We also want to understand how these medicines behave in the body – for example, how much enters the bloodstream and how long it stays there. A big part of the study is to see if these new combinations can help control the cancer, such as by shrinking tumours or stopping their growth.
By testing these different combinations, scientists hope to find more effective and safer treatments for non-small cell lung cancer. The information gathered from this study will be crucial in developing better ways to help people living with this condition.
Key takeaways
- This study explores new drug combinations for advanced non-small cell lung cancer.
- It's a Phase II study, focusing on safety and early signs of effectiveness.
- Researchers will monitor side effects and how cancer responds to treatment.
- Participation involves regular hospital visits for medication, tests, and checks.
- The study aims to discover better future treatments for this cancer.
Who may be eligible?
To join the LIBRA study, you must be at least 18 years old. There's no upper age limit, so older adults are welcome to participate. The study is open to both men and women.
The most important requirement is that you have non-small cell lung cancer that is considered 'locally advanced' (meaning it has grown significantly in the area where it started) or 'metastatic' (meaning it has spread to other parts of the body). Your cancer would need to meet specific criteria that the study doctors will check.
There will be other detailed health checks to make sure the study is a good fit for you and safe. These usually involve reviewing your medical history, any other health conditions you have, and the treatments you've received before. Your study doctor and nurse will go through all these details with you.
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 non-small cell lung cancer that is locally advanced or has spread?
- Are you able to attend regular hospital appointments?
- Are you prepared to undergo various medical tests, like blood tests and scans?
What does participation involve?
If you decide to take part in the LIBRA study, you would receive one of the new combinations of medicines being tested. This would be given at a hospital or clinic, which are referred to as 'multi-centre' because the study is happening in several locations. You would have regular appointments to monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These appointments will involve blood tests, scans (like CT scans), and physical exams.
The doctors will also be checking how the medicines work in your body by taking blood samples to measure drug levels. They'll also look for any immune system reactions to the drugs. The exact number of visits, tests, and the total duration of your participation will depend on the specific treatment you receive and how your body responds to it. You will be closely monitored throughout your time in the study and during a follow-up period after treatment ends.
Potential risks and benefits
Locations (3)
- —UnverifiedFrance
- —UnverifiedItaly
- —UnverifiedSpain
Common questions
What is 'non-small cell lung cancer'?
It's the most common type of lung cancer, and this study focuses on cases that are advanced or have spread.
What does 'Phase II study' mean?
It's an early stage of clinical research where doctors look mainly at how safe a new treatment is and if it shows early signs of working, usually in a smaller group of people.
What kinds of problems are they looking for?
Doctors are carefully watching for any side effects, known as 'adverse events,' to understand the safety of the new drug combinations.
Will this study guarantee to shrink my tumour?
No, there's no guarantee the treatment will shrink your tumour. Researchers are investigating if these new combinations have that effect.
How long will I be in the study?
The duration of your participation will depend on how you respond to the treatment and the study's specific plan, which your doctor will explain.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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