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Looking for participantsPhase3

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

Sponsor: Boehringer Ingelheim

NCT ID: NCT07195695

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Zongertinib (drug), Pembrolizumab (drug), Atezolizumab (drug), Durvalumab (drug)
How long the study runs
Study runs about 128 months (dates as stated)
About the drug or intervention
Zongertinib — drug: Zongertinib · Pembrolizumab — drug: Pembrolizumab · Atezolizumab — drug: Atezolizumab · Durvalumab — drug: Durvalumab · Nivolumab — drug: Nivolumab
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
400
Started
2026-01-16
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for non-small cell lung cancer
  • • Phase3 - 400 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with non-small cell lung cancer

Where?

  • • Cardiff - Velindre Cancer Centre
  • • Edinburgh - Western General Hospital
  • • London - Guy's Hospital
  • • London - The Royal Marsden Hospital, Chelsea
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy and safety of zongertinib as adjuvant therapy in participants with completely resected Stage II-IIIB NSCLC and HER2 TKD-activating mutations. Participants must have undergone complete resection and received perioperative systemic therapy consistent with current standards, including either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy. After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status. The primary objective is to evaluate whether zongertinib improves disease-free survival (DFS) compared with standard treatment. Secondary objectives include overall survival (OS), safety, tolerability, and patient-reported outcomes.

Non-small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2CD56EGFRALK

What the study is looking for

  • ✓Signed and dated written agreement to take part in accordance with ICH-GCP and local legislation prior to admission to the...
  • ✓Patients must be ≥18 years old or over the legal age of consent in their country
  • ✓HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2)...
  • ✓Histology and tumor sample: confirmed by a biopsy diagnosis of primary NSCLC
  • ✓An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to...

Who cannot take part

  • ✗Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
  • ✗Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
  • ✗Treatment with radiotherapy for primary NSCLC
  • ✗Co-occurring actionable mutation with approved treatment that targets specific changes in the cancer (e.g. Epidermal growth factor receptor (EGFR) or...
  • ✗Any investigational drug within 5 half-lives of the compound or any of its related material, if known
See the full criteria
Inclusion criteria: 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 criteria: 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.

Where Is This Study? (6 UK sites)

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

Recruiting
Site contact (verified)

Guy's Hospital

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)

The Royal Marsden Hospital, Chelsea

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)

The Christie Hospital

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)

The Royal Marsden Hospital, Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10