1479-0032 Beamion LUNG-3
Research type
Research Study
Full title
Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
IRAS ID
1012818
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
Study for adults who have early-stage non-small cell lung cancer (NSCLC) with a specific change in a gene called HER2. This change leads to a faulty HER2 protein, which can cause cancer cells to grow. People can join if their lung cancer was removed by surgery, and they have received certain 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, compared to standard treatment. In this study, participants are assigned by chance to one of two treatment groups, with an equal chance. One group takes zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This 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 depends on treatment and how long 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 scheduled visits. Doctors check for 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.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0215
Date of REC Opinion
16 Jan 2026
REC opinion
Further Information Favourable Opinion