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
18 Years and older, Male and Female
1479-0032 (primary)
NCI-2025-08625
2025-521284-12-00
U1111-1320-6149
Summary
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.
Eligibility
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients must be =18 years old or over the legal age of consent in their country
- Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
- HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
- Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
- An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
- Staging: Pretherapeutic classification not exceeding Stage IIIB
- Performance status and organ function:
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate organ function based on laboratory values Further inclusion criteria apply.
Treatment Sites in Georgia
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com
157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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