Safety, Immunogenicity and Preliminary Clinical Activity Study of PDC*lung01 Cancer Vaccine in NSCLC
This study is for adults in the UK with non-small cell lung cancer. It's investigating a new treatment called PDC*lung01, which is a cancer vaccine. Researchers want to see if this vaccine is safe and if it helps the body's immune system fight the cancer. They are also checking if it shows promise in treating the disease, either by itself or when given together with other standard lung cancer medicines like Keytruda or Alimta. The study involves different groups of patients, some of whom have had surgery for earlier-stage cancer, while others have more advanced cancer. The vaccine is given through injections, and participants will have regular check-ups to monitor their health and the vaccine's effects. The aim is to find out if this new vaccine could be a helpful future treatment option.
At a glance
What is this study about?
This research is looking at a new treatment called PDC*lung01, which is a specially designed vaccine for people with Non Small Cell Lung Cancer (NSCLC). Researchers want to understand if this vaccine is safe to use and how well people's bodies tolerate it. They also want to see if it helps your immune system learn to fight the cancer cells. This is a very important first step in developing new cancer treatments.
NSCLC is the most common type of lung cancer. This study is testing PDC*lung01 in different ways. Some patients will receive the vaccine by itself, while others might get it alongside other well-known cancer drugs, such as Keytruda or Alimta. This helps the researchers see how the new vaccine works in different situations and if combining it with existing treatments can make them more effective.
The study is being carried out in two stages (Phase 1 and Phase 2). The first stage (Phase 1) is mainly focused on safety and finding the best dose of the vaccine. The second stage (Phase 2) looks more closely at whether the vaccine has a positive effect on the cancer. By doing this research, doctors hope to find new and better ways to treat non-small cell lung cancer in the future.
Key takeaways
- This study is testing a new cancer vaccine for Non Small Cell Lung Cancer.
- It aims to check the vaccine's safety and how the immune system reacts.
- The vaccine may be given alone or with other standard cancer medicines.
- Participation involves injections, regular check-ups, and long-term monitoring.
- It's a Phase 1/2 study, meaning it's an early stage of research to find new treatments.
Who may be eligible?
This study is looking for adults who have been diagnosed with Non Small Cell Lung Cancer (NSCLC). Firstly, your blood will be tested to see if you have a specific genetic marker called HLA-A*02:01. Only people with this marker can take part.
Your specific cancer diagnosis also plays a role. If you've had surgery for earlier-stage NSCLC (stage IIa, IIb, or IIIa) and possibly chemotherapy, you might be eligible. If you have more advanced NSCLC (stage IV), you could also be considered, especially if you've already had platinum-based chemotherapy. If you are starting anti-PD-1 treatment for advanced NSCLC, you might also be eligible for certain parts of the study. Your doctor will know if your particular situation fits the study's requirements.
The study carefully checks everyone's medical history to make sure it's safe for them to take part. It's important that your cancer is confirmed by a tissue sample (biopsy) and that you meet other specific health criteria, which your doctor will review 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 an adult (18 or over)?
- Have you been diagnosed with Non Small Cell Lung Cancer?
- Are you willing to have a blood test for a specific genetic marker (HLA-A*02:01)?
- Have you had, or are you about to start, specific treatments for your lung cancer (e.g., surgery, chemotherapy, anti-PD-1)?
- Are you able to attend regular appointments for the study?
What does participation involve?
If you decide to take part, the study is split into three main parts. First, there's a pre-screening step to check for a specific genetic marker. If you have it, you'll then go through a full screening to make sure you meet all the health requirements.
Next is the 'active period' where you'll receive the PDC*lung01 vaccine. This involves several visits where you'll get injections. Some injections might be under the skin, and others directly into a vein. The vaccine dosage might be low or high depending on which group you're in. For some patients, the vaccine will be given around the same time as other cancer treatments like anti-PD-1. You'll have regular appointments to monitor your health and how you're responding to the treatment. This active treatment phase includes visits for the vaccine and then follow-up visits shortly after your last injection.
Finally, there's a 'follow-up period' that lasts up to two years after your first treatment. During this time, the research team will continue to monitor your health and the progress of your cancer. The total length of your participation, from your first dose to the end of follow-up, could be up to two years.
Potential risks and benefits
Locations (16)
- Grand Hôpital de CharleroiVerified postcodeCharleroi, Belgium
- Jessa ZiekenhuisVerified postcodeHasselt, Belgium
- AZ GroeningeVerified postcodeKortrijk, Belgium
- University Hospitals KU LeuvenVerified postcodeLeuven, Belgium
- CHU Liège- Sart TilmanVerified postcodeLiège, Belgium
- AZ Delta vzwVerified postcodeRoeselare, Belgium
- AZ Sint-NikolaasVerified postcodeSint-Niklaas, Belgium
- CHU GrenobleVerified postcodeGrenoble, France
- Centre Léon Bérard, Centre de lutte contre le cancerVerified postcodeLyon, France
- CHU NantesVerified postcodeNantes, France
- Kliniken der Stadt Köln GmbHVerified postcodeCologne, Germany
- Universitätsklinikum FranlkfurtVerified postcodeFrankfurt am Main, Germany
Common questions
What is Non Small Cell Lung Cancer?
It's the most common type of lung cancer. This study is for people with different stages of this specific type of cancer.
What is PDC*lung01?
It's a new type of cancer vaccine that researchers are testing to see if it can help your body fight lung cancer cells.
Will I have to stop my current cancer treatment to join?
Not necessarily. For some patients, the vaccine is given alongside other standard treatments like Keytruda or Alimta.
How will the vaccine be given?
The vaccine will be given as injections, either under your skin or directly into a vein, at different study visits.
How long will I be in the study?
If you join, your involvement could last up to two years, including active treatment and a follow-up period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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