A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

To join this study, you need to be at least 18 years old. Doctors will need to be able to measure your cancer, for example, on scans. You'll also need to provide a small sample of your cancer tissue, maybe from a past biopsy or a new one if it's safe to do so. Your general health and how well your body's organs are working will also be checked.

This study is for people with advanced non-small cell lung cancer that has either spread or come back. The type of lung cancer (squamous or non-squamous) is important too, as some parts of the study are for specific types. Depending on which part of the study you join, you might have had previous treatments for your advanced cancer (like chemotherapy or immunotherapy) or you might not have had any yet.

There are also specific requirements about any genetic changes in your cancer. For instance, if your cancer has certain common genetic changes that already have targeted treatments available, you might not be eligible for certain parts of this study.

If you decide to take part in this study, after an initial screening to make sure you're suitable, you would enter a treatment phase. You would receive the study drugs (BNT326 and BNT327, possibly with pembrolizumab or standard care) until your cancer gets worse, you feel it's no longer right for you, or for a maximum of two years, whichever comes first. This means regular visits for treatment and check-ups.

After treatment ends, there will be follow-up periods. These include a safety follow-up to monitor any side effects, an efficacy follow-up to see how your cancer has responded over time, and a long-term survival follow-up. In total, the treatment and follow-up periods are expected to last about 3 years, but could be longer if you are still benefiting from the treatment and your doctor agrees.