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

Recruiting now · Phase 3

Conditions studied: Non-small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07195695

Run by

Boehringer Ingelheim

People needed

400

Starts

2026-01-16

Expected to finish

2036-09-02

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 radiation therapy for primary NSCLC
• Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
• Any investigational drug within 5 half-lives of the compound or any of its related material, if known
• 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 it is running

• Centro Oncologico Korben — CABA, Argentina (enrolling)
• Austin Health — Heidelberg, Victoria, Australia (enrolling)
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States (enrolling)
• Hospital Britanico de Buenos Aires — CABA, Argentina (enrolling)
• Clinica Adventista Belgrano — CABA, Argentina (enrolling)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (enrolling)
• OPN Healthcare, Inc. — Glendale, California, United States (enrolling)
• Community Cancer Trials of Utah — Ogden, Utah, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación) — CABA, Argentina (enrolling)
• ClinRé 001-022 (Premier Cancer Care and Infusion Center) — Fresno, California, United States (enrolling)
• Sarcoma Oncology Center — Santa Monica, California, United States (enrolling)
• University of California Los Angeles — Santa Monica, California, United States (enrolling)
• University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States (enrolling)
• Duly Health and Care - Lisle — Lisle, Illinois, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Cancer Care Specialists — Reno, Nevada, United States (enrolling)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
• Mid Florida Hematology and Oncology Center — Orange City, Florida, United States (enrolling)
• Piedmont Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Providence Cancer Institute — Portland, Oregon, United States (enrolling)
• Northwest Georgia Oncology Centers — Marietta, Georgia, United States (enrolling)
• Hendrick Health — Abilene, Texas, United States (enrolling)
• St John of God Subiaco Hospital — Subiaco, Western Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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