First-in-human phase I/IIa study investigating inhaled CIS-DPI as add-on treatment in Stage IV NSCLC patients
Doctors are studying a new inhaled medicine called CIS-DPI for people who have advanced non-small cell lung cancer (Stage IV). This is an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to see if the medicine is safe and what dose can be given, as well as to get an idea of how well it helps manage the cancer when used alongside current treatments. It's open to adults aged 18 and over, regardless of their sex. This research is important for finding new ways to help people living with lung cancer.
At a glance
What is this study about?
This research is looking into a new inhaled medicine, CIS-DPI, for people diagnosed with advanced non-small cell lung cancer. This particular type of lung cancer is often treated with different medicines, and doctors are always searching for new options to improve care.
This study is in its early stages (called Phase I and Phase II). This means it's one of the very first times this inhaled medicine is being given to people. The main reason for doing these early phases is to check if the medicine is safe and to find the right amount (dose) that can be given without causing too many problems. It also aims to see if there are any early signs that the medicine is helping to fight the cancer when used along with other standard treatments.
Finding new, effective, and safe treatments for advanced lung cancer is a key area of medical research. Studies like this are vital for testing potential new medicines and bringing them closer to people who might benefit from them in the future. By participating, individuals contribute to this important progress.
Key takeaways
- This study is for people with advanced non-small cell lung cancer.
- It's testing a new inhaled medicine (CIS-DPI) alongside existing treatments.
- The main goals are to check the medicine's safety and see how well it works.
- It's an early-stage study (Phase I/IIa) being done for the first time in people.
- Adults aged 18 and over are invited to consider taking part.
- Taking part helps research into future lung cancer treatments.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 years or older. All sexes are welcome to take part. The study is specifically for people who have been diagnosed with advanced non-small cell lung cancer, which is sometimes referred to as Stage IV.
While the basic requirements are straightforward, there will be other medical checks and tests to make sure the study medicine is safe for you. For example, your overall health, how your cancer has responded to previous treatments, and other existing health conditions will need to be carefully assessed by the study doctors.
It's important to remember that not everyone who meets the basic requirements will be able to join. The medical team running the study will carefully review all your health information to ensure your safety and that the study is right for 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?
- Have you been diagnosed with advanced non-small cell lung cancer (Stage IV)?
- Are you able to take an inhaled medicine?
- Are you currently receiving treatment for your lung cancer?
- Are you comfortable with regular hospital visits and medical tests?
What does participation involve?
If you decide to take part, you will be given the new inhaled medicine, CIS-DPI, in addition to your usual cancer treatment. You will also have regular visits to the hospital or clinic. These visits will involve various checks, such as blood tests, physical examinations, and scans, to monitor your health and how the medicine is affecting your cancer. The study team will explain the schedule of these visits and what will happen at each one. There will also be follow-up appointments after you stop taking the study medicine to make sure you remain well and to collect final information. The total duration of your involvement could vary, but the study team will provide a clear timeline during your initial discussions.
Potential risks and benefits
Locations (3)
- —UnverifiedBelgium
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is 'Non-Small Cell Lung Cancer'?
It's a common type of lung cancer. 'Stage IV' means it's advanced and has spread to other parts of the body.
What does 'inhaled CIS-DPI' mean?
CIS-DPI is the name of the new medicine being tested. 'Inhaled' means you breathe it in, similar to an asthma inhaler.
What is a 'Phase I/IIa study'?
It's an early-stage study. Phase I checks if the medicine is safe, and Phase IIa looks at safety and if it shows early signs of working.
Will I still get my usual cancer treatment?
Yes, the new medicine is given 'as add-on treatment', meaning it's taken alongside your current cancer medicines.
Do I have to be a specific age?
You must be 18 years old or over to be eligible for this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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