Beamion LUNG-3: Zongertinib for HER2-Mutated Lung Cancer

This study, called Beamion LUNG-3, is looking at whether a drug called zongertinib can help people with a specific type of lung cancer. You might be able to join if you have non-small cell lung cancer (NSCLC) that has been completely removed by surgery, is Stage II-IIIB, and has a HER2 gene mutation. Zongertinib is a targeted therapy, meaning it focuses on specific changes in cancer cells. Participants will receive either zongertinib or standard treatment, which could include other approved immunotherapies like pembrolizumab, atezolizumab, durvalumab, or nivolumab, or observation. The main goal is to see if zongertinib helps people live longer without their cancer returning (disease-free survival). The study is planning to enroll 400 people, but its current status is unclear.

Study design
This is a global, randomized, open-label study, meaning participants are randomly assigned to a treatment group and both you and your doctors will know which treatment you are receiving. It plans to include 400 participants.
What's involved
Participants will take zongertinib orally once daily for up to 3 years, or receive standard treatment which may include an approved adjuvant immunotherapy or observation. You must have signed a consent form and be able to use effective birth control if you are a woman of childbearing potential.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, disease-free survival, will be measured for up to 8 years and 5 months.

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NCT07195695

Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~400 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ZongertinibPembrolizumabAtezolizumabDurvalumabNivolumab

At a glance

Recruiting sites
161 of 202 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival (DFS) by investigator's assessment
Measured over up to 8 years and 5 months
Non-small Cell Lung Cancer
202 sites across 44 states
China28
Japan25
Spain14
Germany9
California8
France8
Italy8
South Korea8

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

Exclusion

Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis
Active infectious disease requiring systemic therapy
Uncontrolled gastrointestinal disorders affecting drug intake/absorption
Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers
  • Disease-free survival (DFS) by investigator's assessmentup to 8 years and 5 months

    DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier