Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

This study is open to adults 18 years and older who have early-stage non-small cell lung
cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes
provide the instructions for making proteins, and this change leads to a faulty HER2
protein. People can join if their lung cancer was removed by surgery, and they have
already received certain other anti-cancer treatments. The purpose of this study is to
find out if a study medicine called zongertinib helps people with this type of cancer
live longer without their cancer coming back after surgery, when compared to standard
treatment. Zongertinib is being developed to target the faulty HER2 protein, which can
cause cancer cells to grow.

In this study, participants are assigned by chance to one of two treatment groups, with
an equal chance of being in either group. One group takes the study medicine,
zongertinib, by mouth once a day for up to 3 years. The other group receives a standard
treatment, chosen by their doctor. This standard treatment may be an immunotherapy
medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular
check-ups without active study medicine (observation).

Participants can be in this study for up to about 11 years. During this time, they visit
the study site regularly for check-ups and study-related tests. The frequency of these
visits varies depending on their treatment and how long they have been in the study. In
addition to visits at the study site, participants in some treatment groups will also
have phone calls with the study team every 3 weeks to check on their health between their
scheduled visits.

Doctors check for any signs of cancer coming back using imaging scans (like CT or MRI
scans); these scans are generally done every 3 months for the first 2 years, then every 6
months for the next 3 years, and then yearly. Participants also fill in questionnaires
about their overall wellbeing, health and symptoms. Throughout the study, doctors also
check participants' health and note any unwanted effects.

Treatment Sites in Georgia