Tests zongertinib after surgery in lung cancer with HER2 mutations
Tests zongertinib versus standard care in adults with resected HER2-mutated lung cancer.
Plain-language title generated from the registry record
Registry title: Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Key facts
- Where
- Hong Kong, Hong KongSee the 4 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose lung cancer (non-small cell, stage II-IIIB) was fully removed by surgery and whose tumor has an activating HER2 mutation. It compares zongertinib with standard treatment.
- Age
- 18 years or older (or over the legal age of consent in the country)
- Sex
- Men and women can join
- Disease stage
- Primary non-small cell lung cancer, stage II-IIIB before treatment, completely removed by surgery
- Earlier treatment
- Must have had surgery meant to remove all of the disease, and drug treatment around the surgery: platinum-based chemotherapy before surgery (with or without immunotherapy) or after surgery. No radiation therapy for the lung cancer.
- Biomarker or test result
- Documented activating HER2 mutation in the tyrosine kinase domain (TKD). An archived tumor sample is sent to a central laboratory to confirm it.
Main reasons for not taking part
- Mixed cell type tumor or positive neuroendocrine markers
- Major surgery within 4 weeks before randomization
- Another treatable gene change such as EGFR or ALK
- Past or current non-infectious lung inflammation (interstitial lung disease or pneumonitis)
- Other cancer in the last 3 years (with some exceptions), or serious heart problems
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07195695, who can take part
Where in Hong Kong
- Prince of Wales Hospital-Hong Kong-20715Hong Kong, Hong KongTaking people
- Princess Margaret HospitalHong Kong, Hong KongTaking people
- Queen Elizabeth Hospital-Hong Kong-51727Hong Kong, Hong KongTaking people
- Queen Mary HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07195695EU 2025-521284-12-00
- Record updated
- 2 November 2026
- Original description
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.Read full original descriptionShow less
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
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
Inclusion: 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.
Exclusion: Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization; Treatment with radiation therapy for primary NSCLC; Any investigational drug within 5 half-lives of the compound or any of its related material, if known; Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK)); History or presence of; 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; Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) >470 msec, or ejection fraction <50% Further exclusion criteria apply; Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56).