Status:
NOT_YET_RECRUITING
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 6 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2036
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07195695
Start Date
February 6 2026
End Date
September 2 2036
Last Update
January 9 2026
Active Locations (177)
Enter a location and click search to find clinical trials sorted by distance.
1
Premier Cancer Care
Fresno, California, United States, 93720
2
OPN Healthcare, Inc.
Glendale, California, United States, 91203
3
Sutter Health
Roseville, California, United States, 95661
4
Sarcoma Oncology Center
Santa Monica, California, United States, 90403