Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Recruiting · NCT07195695 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
60 locations listed across 14 US states.
- ClinRé 001-022 (Premier Cancer Care and Infusion Center) - Fresno, California, United States
- OPN Healthcare, Inc. - Glendale, California, United States
- University of California Irvine - Orange, California, United States
- Sutter Health - Roseville, California, United States
- University of California San Francisco - San Francisco, California, United States
- Sarcoma Oncology Center - Santa Monica, California, United States
- University of California Los Angeles - Santa Monica, California, United States
- Northern California Kaiser Permanente - Vallejo, California, United States
- George Washington University Cancer Center - Washington D.C., District of Columbia, United States
- Mid Florida Hematology and Oncology Center - Orange City, Florida, United States
- Piedmont Cancer Institute - Atlanta, Georgia, United States
- Northwest Georgia Oncology Centers - Marietta, Georgia, United States
- Saint Alphonsus Regional Medical Center - Boise - Boise, Idaho, United States
- Northwestern University - Chicago, Illinois, United States
- University of Illinois Hospital and Health Sciences System - Chicago, Illinois, United States
- Duly Health and Care - Lisle - Lisle, Illinois, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Cancer Care Specialists - Reno, Nevada, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York, New York, United States
- Memorial Sloan-Kettering Cancer Center - New York, New York, United States
- Levine Cancer Institute - Charlotte, North Carolina, United States
- Durham VA Health Care System - Durham, North Carolina, United States
- Providence Cancer Institute - Portland, Oregon, United States
- Hendrick Health - Abilene, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Community Cancer Trials of Utah - Ogden, Utah, United States
- Virginia Cancer Specialists, PC - Fairfax, Virginia, United States
- Adana Şehir Hastanesi - Adana, Turkey (Türkiye)
- Medical Park Seyhan Hastanesi - Adana, Turkey (Türkiye)
- Aichi Cancer Center Hospital - Aichi, Nagoya, Japan
- Fujita Health University Hospital - Aichi, Toyoake, Japan
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL) - Amsterdam, Netherlands
- Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi - Ankara, Turkey (Türkiye)
- Ankara University Medical Faculty Hospital - Ankara, Turkey (Türkiye)
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi - Ankara, Turkey (Türkiye)
- Henry Dunant Hospital, Athens - Athens, Greece
- Chest Hospital of Athens "Sotiria" - Athens, Greece
- University General Hospital Attikon - Athens, Greece
- Hospital del Mar - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Istituto Tumori Giovanni Paolo II - Bari, Italy
- Hospital de Amor - Barretos, Brazil
- China-Japan Friendship Hospital - Beijing, China
- Beijing Chest Hospital, Capital Medical University - Beijing, China
- Charité - Universitätsmedizin Berlin - Berlin, Germany
- Hopital Louis Pradel - Bron, France
- Lotus Med - Bucharest, Romania
- Memorial Healthcare International - Bucharest, Romania
- Hospital Universitario De Burgos - Burgos, Spain
- Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion) - CABA, Argentina
- Hospital Britanico de Buenos Aires - CABA, Argentina
- Centro Oncologico Korben - CABA, Argentina
- Clinica Adventista Belgrano - CABA, Argentina
- Velindre Cancer Centre - Cardiff, United Kingdom
- The First Hospital of Jilin University - Changchun, China
- Xiangya Hospital, Central South University - Changsha, China
- Hunan Province Tumor Hospital - Changsha, China
- Sichuan Cancer Hospital - Chengdu, China
- West China Hospital, Sichuan University - Chengdu, China
- National Cancer Center Hospital East - Chiba, Kashiwa, Japan
Showing 60 of 202 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →