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Taking people in BrazilPhase 3

Tests zongertinib after surgery in lung cancer with HER2 mutations

Tests zongertinib versus standard care in adults with resected HER2-mutated lung cancer.

Key facts

Who runs it
Boehringer Ingelheim
Where
Barretos, Maceió, Natal, Porto Alegre, Santo André, and São Paulo, BrazilSee the 7 sitesAlso in 27 other countries, 197 sites
Trial code
Registry title
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Status
Recruiting
Phase
Phase 3
People taking part
400 people, planned
Started
16 Jan 2026
Expected to end
2 Sept 2036
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Zongertinib
  • Pembrolizumab
  • Atezolizumab
  • Durvalumab
  • Nivolumab
Record updated
2 November 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Check if you might fit

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?

Where in Brazil

Also in 27 other countries, 197 sites

  • Hospital de AmorBarretos, BrazilContact: Boehringer IngelheimTaking people
  • NewData Clinical Research - MaceióMaceió, BrazilContact: Boehringer IngelheimTaking people
  • Centro de Pesquisa Oncology NatalNatal, BrazilContact: Boehringer IngelheimTaking people
  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e PesquisaPorto Alegre, BrazilContact: Boehringer IngelheimTaking people
  • CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaSanto André, BrazilContact: Boehringer IngelheimTaking people
  • A.C. CamargoSão Paulo, BrazilContact: Boehringer IngelheimTaking people
  • Icesp - Instituto Do Câncer Do Estado de São PauloSão Paulo, BrazilContact: Boehringer IngelheimTaking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Zongertinib treatment armTreatment being tested

    Treatment: Zongertinib

  • Standard of Care (SoC) treatment armExisting treatment, for comparison

    Treatment: Pembrolizumab, Atezolizumab, Durvalumab, and Nivolumab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official 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
Plain-language title
Tests zongertinib after surgery in lung cancer with HER2 mutationsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07195695, who can take part
Record updated
2 November 2026