Safety and Preliminary Efficacy of Pumitamig (BNT327), an Investigational Therapy for Patients With Non-small Cell Lung Cancer in Combination With Chemotherapy as First-line or Second-line Treatment

To be able to join this study, you would need to have non-small cell lung cancer that has spread to other parts of your body (advanced or metastatic) and has gotten worse after your first treatment. This previous treatment must have included both immunotherapy and chemotherapy. Your doctor will need to confirm your cancer diagnosis and that it has grown or spread since your last treatment.

Also, your doctor will need to be able to measure at least one of your cancer spots on a scan. You will need to provide samples of your cancer tissue from the past 18 months. For some participants, a new tissue sample will be needed at the start of the study, and another one during treatment. You should generally be fairly active and able to carry out most daily tasks, and your organs (like your liver and kidneys) should be working well. Your doctor will check all these details.

There are also reasons why you might not be able to join, though these are not fully listed here. For example, if you have certain other serious health problems or have had specific treatments recently, you might not be eligible. Your study doctor will discuss all the detailed requirements with you.

If you decide to take part in this study, you will receive the new medicine, pumitamig, along with docetaxel chemotherapy. These treatments will continue until your cancer starts to grow again, if you experience side effects that are too difficult to manage, or for up to two years, whichever comes first. You can also choose to stop being part of the study at any time.

Initially, a small number of people will join to help find the best dose. Once that dose is found, more people will join. Some people in the later part of the study will be asked to provide an additional tissue sample from their tumour at the beginning of the study and another one during their treatment, plus the usual samples. Throughout the study, you will have regular visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor for any side effects.

After you finish the study treatment, you will still be followed closely. This means doctors will keep in touch with you to check on your health, how your cancer is doing, if you receive any new cancer treatments, and your overall survival status. This long-term follow-up is important for understanding the full effects of the study treatment.