NEOVACC: A personalised DNA vaccine for patients with advanced lung cancer

This study is looking for adults aged 18 to 100 years old who have advanced or recurring non-small cell lung cancer (NSCLC). To be considered, your cancer must show a certain marker (PDL1 expression of 50% or more) and you must already be receiving anti-PD1 treatment (like pembrolizumab) as your standard care. You also need to have completed at least 3 cycles of this treatment, and your cancer should have shown some response (stable disease or partial improvement), or progression that allows time for the vaccine to be made.

Unfortunately, you cannot take part if your cancer has completely gone away with previous treatments, or if your doctor thinks anti-PD1 treatment alone is working very well for you. You also cannot join if your cancer is progressing too quickly to wait for the vaccine, or if you have certain health conditions like active autoimmune diseases (unless it's a mild skin condition like eczema or psoriasis that doesn't need strong medication).

Other reasons you might not be able to join include if you've recently had chemotherapy, are on other experimental medicines, have inflammatory bowel disease, or if you've had certain serious immune-related side effects from previous treatments. Women who are pregnant, breastfeeding, or planning to become pregnant cannot participate due to unknown effects on a baby.

If you join the study, you will continue to receive your standard pembrolizumab treatment for up to two years. A small sample of your cancer tissue (a biopsy) will be taken to create your unique vaccine. While your vaccine is being made, you will keep receiving pembrolizumab.

Once your vaccine is ready, you will receive it every three weeks for the first 24 weeks, and then every six weeks after that for as long as you are in the trial. The vaccine is given into a muscle using a special needle-free injector. The pembrolizumab and vaccine treatments will run together for a maximum of two years.

Throughout the study, your cancer will be closely monitored with scans. You'll also have blood samples taken regularly, and on two occasions, you'll have a slightly larger blood collection called leukapheresis, which helps gather specific immune cells. You may also need additional biopsies of your cancer tissue during treatment. To make things easier, many follow-up visits will be combined with your existing hospital appointments. The total duration of your participation could be up to two years.