Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

This study is looking for adults aged 18 or older who have advanced non-small cell lung cancer. A key requirement is that your cancer must have a specific genetic change called a HER2 mutation, which your doctors will need to confirm. It's also important that you haven't yet received any treatment for your advanced lung cancer.

To be considered, your doctors will also need to see that your cancer can be measured, typically with scans. You should also be well enough to receive at least one of the standard treatments used in this study. There are some other medical conditions or past cancer diagnoses that might mean you can't join, so the study team will review your full medical history carefully.

If you decide to take part, the study could last up to about 5 years and 10 months (70 months). You will visit the study site roughly every three weeks for check-ups and treatments. During these visits, doctors will regularly monitor your health and how you're feeling. They will also take notes of any new or unwanted effects you might experience.

To see how your cancer is responding, you will have CT or MRI scans at the start of the study and then every 6 weeks for the first 18 months. After that, scans will be every 12 weeks. You'll also be asked to fill out questionnaires about your symptoms and how the treatment is affecting your daily life. You'll be randomly assigned to one of two groups: one will receive the new medicine, zongertinib, and the other will receive the standard combination of pembrolizumab and chemotherapy (cisplatin or carboplatin with pemetrexed).