Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Boehringer Ingelheim
- Interventions being studied
- Drug: Zongertinib; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Durvalumab; Drug: Nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- ClinRé 001-022 (Premier Cancer Care and Infusion Center)Fresno, California
- OPN Healthcare, Inc.Glendale, California
- University of California IrvineOrange, California
- Sutter HealthRoseville, California
- University of California San FranciscoSan Francisco, California
- Sarcoma Oncology CenterSanta Monica, California
- University of California Los AngelesSanta Monica, California
- Northern California Kaiser PermanenteVallejo, California
- George Washington University Cancer CenterWashington D.C., District of Columbia
- Mid Florida Hematology and Oncology CenterOrange City, Florida
- Piedmont Cancer InstituteAtlanta, Georgia
- Northwest Georgia Oncology CentersMarietta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.