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RecruitingLast updated: 17 July 2026

Beamion LUNG-3: Testing whether a targeted treatment can reduce the risk of HER2-mutated non-small cell lung cancer coming back after surgery compared with standard careA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18+

Trial acronym

Beamion LUNG-3

Clinical summary

Summary

This study is looking at whether zongertinib, a targeted cancer treatment taken as a tablet, can help prevent non-small cell lung cancer (NSCLC) from coming back after surgery.

The trial is for people who:

  • have Stage II to Stage IIIB non-small cell lung cancer (NSCLC)
  • have a specific change (mutation) in the HER2 gene (TKD-activating mutations)
  • have had surgery to completely remove their cancer
  • have already received standard chemotherapy before or after surgery, with or without immunotherapy

What is involved?
Participants will be randomly assigned (by chance) to one of two groups:

  • Zongertinib, taken by mouth once a day for up to 3 years
  • Standard care, which may include approved immunotherapy or regular check-ups and monitoring without additional treatment, depending on usual local practice and individual circumstances.

Neither participants nor doctors can choose which group they are assigned to.

What is the aim of the study?
The main aim is to find out whether zongertinib can help people stay free from cancer for longer compared with standard care.

Researchers will also monitor:

  • Overall survival
  • Side effects and safety
  • Quality of life and participants' experiences during treatment

 

Conditions

This trial is treating people with non-small cell lung cancer with an TKD-activating HER2 mutation

Eligibility

Inclusion

  1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  2. Patients must be ≥18 years old or over the legal age of consent in their country
  3. 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
  4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
  5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
  6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
  7. Staging: Pretherapeutic classification not exceeding Stage IIIB

  8. 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

  1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
  2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
  3. Treatment with radiation therapy for primary NSCLC
  4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
  5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known

  6. 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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07195695 *
  • 2025-521284-12-00 *
  • 1479-0032; U1111-1320-6149

Trial sponsor

Boehringer Ingelheim

Scientific Title

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

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