Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
18 Years and older, Male and Female
1479-0032 (primary)
NCI-2025-08625
2025-521284-12-00
U1111-1320-6149
Summary
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.
Objectives
This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy
and safety of zongertinib as adjuvant therapy in participants with completely resected
Stage II-IIIB NSCLC and HER2 TKD-activating mutations.
Participants must have undergone complete resection and received perioperative systemic
therapy consistent with current standards, including either neoadjuvant platinum-based
chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
After completing surgery and required systemic treatment, eligible participants are
randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years,
or standard treatment, which may include an approved adjuvant immunotherapy agent
administered according to its label, or observation, depending on local clinical practice
and patient status.
The primary objective is to evaluate whether zongertinib improves disease-free survival
(DFS) compared with standard treatment. Secondary objectives include overall survival
(OS), safety, tolerability, and patient-reported outcomes.
Eligibility
- 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.
Treatment Sites in Georgia
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com
6002 Professional Parkway
Suite 140
Douglasville, GA 30134
770-281-5101
www.ngoc.com
157 Clinic Avenue
Suite 202
Carrollton, GA 30117
770-281-5101
www.ngoc.com
340 Kennestone Hospital Blvd.
Suite 100
Marietta, GA 30060
770-281-5101
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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