An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC)
This research is looking into a new treatment for a type of lung cancer called non-small-cell lung cancer. It involves a special cancer vaccine, known as PDC*lung01. The study is split into two main parts. The first part focuses on making sure the new vaccine is safe for people to use and how well they can cope with any side effects. It's also checking if the vaccine, either by itself or when given along with another cancer drug (an anti-PD-1 treatment), shows early signs of working against the cancer. Understanding these points is crucial for developing new ways to treat lung cancer, aiming to improve patients' health and quality of life.
At a glance
What is this study about?
This study is investigating a new treatment approach for a common type of lung cancer called non-small-cell lung cancer. The main focus is on a special type of cancer 'vaccine' known as PDC*lung01. Although we often think of vaccines preventing diseases, this one is designed to help your body's immune system fight existing cancer cells. Researchers want to see if this vaccine is safe, how well people tolerate it, and if it can help the immune system recognise and attack the cancer.
The study also looks at whether the vaccine works better when given alongside another type of cancer drug called an anti-PD-1 treatment. This type of drug is known as immunotherapy and helps to 'unblock' your immune system, allowing it to work more effectively against cancer. By combining these treatments, doctors hope to find a more powerful way to tackle non-small-cell lung cancer.
This research is in its early stages (Phase I and II), meaning it's one of the first times this vaccine is being used in people. The aim is to carefully monitor participants for any side effects and to see if the treatment shows encouraging signs of shrinking the tumour or preventing it from growing. This information is vital for deciding if the treatment can be developed further and potentially help many more patients in the future.
Key takeaways
- The study is testing a new cancer vaccine (PDC*lung01) for non-small-cell lung cancer.
- It aims to see if the vaccine is safe and if it helps fight cancer, possibly with another drug (anti-PD-1).
- It's an early-stage study, so researchers are carefully monitoring side effects and early signs of effectiveness.
- Participants must be 18 or older and have non-small-cell lung cancer.
- Regular hospital visits, blood tests, and scans will be part of taking part.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also participate.
This study is open to both men and women. The specific type of cancer you have must be non-small-cell lung cancer.
There might be other health conditions or treatments that would mean you can't join the study, but these details would be discussed with you by the study team. They need to make sure the study is safe for you and that the results will be clear.
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?
- Are you willing to attend regular hospital visits and have blood tests/scans?
- Are you able to understand and be comfortable with the study's requirements?
What does participation involve?
If you decide to take part, the first step is a check-up to make sure the study is right for you. This will involve several tests, which may include blood samples, scans, and possibly other examinations to understand your health and your cancer.
Once enrolled, you would receive the study treatments, which could be the PDC*lung01 vaccine, or chemotherapy drugs like ALIMTA, or immunotherapy like KEYTRUDA, or a combination. These would typically be given as infusions into a vein. The timing and number of these treatments would depend on which group you are in and how you respond.
Throughout the study, you'll have regular visits to the hospital or clinic for blood tests, check-ups, and to monitor for any side effects. You'd also have scans to see how the cancer is responding to the treatment. This close monitoring would continue until 28 days after your last dose of the study drug, and there may be longer-term follow-up to track your health progress.
Potential risks and benefits
Locations (5)
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedBelgium
Common questions
What is non-small-cell lung cancer?
It's the most common type of lung cancer. This study focuses on finding new treatments for it.
What is PDC*lung01?
It's a new type of 'cancer vaccine' being tested to help your body's immune system fight lung cancer cells.
What is an anti-PD-1 treatment?
This is another cancer drug (immunotherapy) that helps 'unblock' your immune system, allowing it to attack cancer more effectively.
What will doctors be looking for in this study?
They'll be checking if the new vaccine is safe, how well people cope with it, and if it shows early signs of shrinking or controlling the cancer.
Can I stop participating in the study if I want to?
Yes, you are free to leave the study at any time, for any reason, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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