A randomized, phase II, open-label, multicenter study investigating efficacy and safety of anti-PD-1/PD-L1 treatment +/- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer
This research study is for people in the UK with advanced or metastatic non-small cell lung cancer that cannot be surgically removed. It aims to see how well a combination of existing immunotherapy and a new vaccine called UV1 works as an initial treatment. Immunotherapy helps your body's immune system fight cancer, and UV1 is designed to boost this response. The study will compare patients receiving standard immunotherapy alone with those receiving immunotherapy plus the UV1 vaccine. Researchers will carefully check if the treatment stops the cancer from growing, how long people live, and how safe the treatments are. They hope to find better ways to treat this type of lung cancer.
At a glance
What is this study about?
This research study is for individuals diagnosed with a specific type of lung cancer called non-small cell lung cancer, which has spread to other parts of the body (metastatic) or is too advanced to be removed by surgery. The main goal of the study is to explore new ways to treat this condition using a combination of medicines.
The study focuses on a type of treatment called immunotherapy, which helps your body's own immune system recognise and fight cancer cells. It combines standard immunotherapy with a new vaccine, UV1. Vaccines usually help prevent diseases, but this cancer vaccine is designed to help your immune system better target existing cancer. Researchers want to see if adding the UV1 vaccine to standard immunotherapy is more effective at stopping the cancer from growing and if it's safe for patients.
By comparing treatment groups, doctors hope to learn if this new combination improves how long patients live without their cancer getting worse, and whether it leads to better overall health outcomes. The findings from this study could help doctors develop more effective treatments for people with advanced lung cancer in the future.
Key takeaways
- This study is for advanced, inoperable non-small cell lung cancer.
- It combines standard immunotherapy with a new UV1 vaccine and Leukine.
- Researchers want to see if the combination works better and is safe.
- Participation involves regular hospital visits for treatment and check-ups.
- You will be closely monitored for cancer progression and side effects.
- You have the right to leave the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old. Both men and women can take part. You must have advanced non-small cell lung cancer that has spread in the body or cannot be surgically removed.
The research team will review your medical history and perform some tests to make sure that the study is a good fit for you and that taking part would be safe. There are specific medical criteria that need to be met to ensure the study is suitable for your individual health situation.
It's important to remember that joining a clinical study is a big decision, and the study team will discuss all the requirements with you in detail.
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 advanced or metastatic non-small cell lung cancer?
- Has your doctor told you your lung cancer cannot be removed by surgery?
- Are you able to travel to study appointments?
- Are you willing to follow the study schedule and procedures?
What does participation involve?
If you decide to take part, you will be assigned to one of two treatment groups. One group will receive standard immunotherapy, while the other will receive standard immunotherapy plus the UV1 vaccine and another medication called Leukine. You won't know which group you are in, and the doctors assessing your progress won't know either to ensure fair results. You will have regular visits to the hospital or clinic for treatment, blood tests, scans, and check-ups to monitor your health and the cancer's response.
The treatment will continue for a period, and you will have follow-up appointments even after treatment ends to see how you are doing in the long term. The total duration of your participation could vary, encompassing active treatment and follow-up monitoring. The study team will explain the full schedule of visits and procedures during your initial discussions.
Throughout your participation, the research team will carefully monitor your health and any side effects you might experience. You will have a dedicated team to support you and answer any questions you have.
Potential risks and benefits
Locations (1)
- —UnverifiedNorway
Common questions
What is immunotherapy?
Immunotherapy helps your body's immune system recognise and fight cancer cells more effectively.
What is the UV1 vaccine?
It's a new vaccine designed to boost your immune system's attack on cancer cells when given alongside immunotherapy.
Will I know which treatment I'm getting?
No, you and the doctors assessing your scans won't know, to ensure the results are unbiased. This is called 'blinded' to ensure fairness.
How long will I be in the study?
This will vary depending on your treatment response and follow-up, but the study team will explain the expected duration.
Can I stop participating at any time?
Yes, you can choose to leave the study at any point, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.