Tests zongertinib after surgery in lung cancer with HER2 mutations
Tests zongertinib versus standard care in adults with resected HER2-mutated lung cancer.
Plain-language title generated from the registry record
Registry title: Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Key facts
- Where
- Aichi, Nagoya, Aichi, Toyoake, Chiba, Kashiwa, Fukuoka, Fukuoka, Fukuoka, Kitakyushu, Hiroshima, Hiroshima, Hokkaido, Sapporo, Kanagawa, Sagamihara, Kanagawa, Yokohama, Miyagi, Sendai, Niigata, Niigata, Okayama, Okayama, Osaka, Hirakata, Osaka, Osaka, Osaka, Sakai, Saitama, Hidaka, Saitama, Kitaadachi-gun, Shizuoka, Sunto-gun, Tochigi, Shimotsuke, Tokyo, Bunkyo-ku, Tokyo, Chuo-ku, Tokyo, Koto-ku, Tokyo, Shinjuku-ku, and Wakayama, Wakayama, JapanSee the 25 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07195695, who can take part
Where in Japan
- Aichi Cancer Center HospitalAichi, Nagoya, JapanTaking people
- Fujita Health University HospitalAichi, Toyoake, JapanTaking people
- National Cancer Center Hospital EastChiba, Kashiwa, JapanNot yet recruiting
- Kyushu University HospitalFukuoka, Fukuoka, JapanTaking people
- Hospital of the University of Occupational and Environmental HealthFukuoka, Kitakyushu, JapanTaking people
- Hiroshima University HospitalHiroshima, Hiroshima, JapanTaking people
- Hokkaido Cancer CenterHokkaido, Sapporo, JapanTaking people
- Kitasato University HospitalKanagawa, Sagamihara, JapanTaking people
- Kanagawa Cancer CenterKanagawa, Yokohama, JapanTaking people
- Sendai Kousei HospitalMiyagi, Sendai, JapanTaking people
- Niigata Cancer Center HospitalNiigata, Niigata, JapanTaking people
- Okayama University HospitalOkayama, Okayama, JapanTaking people
- Kansai Medical University HospitalOsaka, Hirakata, JapanTaking people
- Osaka International Cancer InstituteOsaka, Osaka, JapanTaking people
- Kindai University HospitalOsaka, Sakai, JapanTaking people
- National Hospital Organization Kinki-Chuo Chest Medical CenterOsaka, Sakai, JapanTaking people
- Saitama Medical University International Medical CenterSaitama, Hidaka, JapanTaking people
- Saitama Cancer CenterSaitama, Kitaadachi-gun, JapanTaking people
- Shizuoka Cancer CenterShizuoka, Sunto-gun, JapanTaking people
- Jichi Medical University HospitalTochigi, Shimotsuke, JapanTaking people
- Juntendo University HospitalTokyo, Bunkyo-ku, JapanTaking people
- National Cancer Center HospitalTokyo, Chuo-ku, JapanTaking people
- Japanese Foundation for Cancer ResearchTokyo, Koto-ku, JapanTaking people
- Tokyo Medical University HospitalTokyo, Shinjuku-ku, JapanTaking people
- Wakayama Medical University HospitalWakayama, Wakayama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Boehringer Ingelheim
- Trial code
- NCT07195695EU 2025-521284-12-00
- Record updated
- 2 November 2026
- Original description
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
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
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.
Inclusion: 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.
Exclusion: 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).