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Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Sponsor: Boehringer Ingelheim
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-01-16
Completion Date
2036-09-02
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Zongertinib
Zongertinib
Pembrolizumab
Pembrolizumab
Atezolizumab
Atezolizumab
Durvalumab
Durvalumab
Nivolumab
Nivolumab
Locations (203)
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
Texas Oncology - Amarillo
Amarillo, 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
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
Instituto Medico Especializado Alexander Fleming
Ciudad Autónoma de Bs As, Argentina
Flinders Medical Centre
Bedford Park, South Australia, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Austin Health
Heidelberg, Australia
Royal North Shore Hospital
Sydney, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Medical University of Innsbruck
Innsbruck, Austria
Clinic Floridsdorf
Vienna, Austria
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Hospital de Amor
Barretos, Brazil
NewData Clinical Research - Maceió
Maceió, Brazil
Centro de Pesquisa Oncology Natal
Natal, Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
A.C. Camargo
São Paulo, Brazil
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centro de Estudios Clinicos SAGA
Providencia, Chile
Bradford Hill- Centro de Investigacion Clinica
Recoleta, Chile
China-Japan Friendship Hospital
Beijing, China
Beijing Chest Hospital, Capital Medical University
Beijing, China
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
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Shandong Cancer Hospital
Jinan, China
Yunnan Provincial Tumor Hospital
Kunming, China
Linyi Cancer Hospital
Linyi, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital
Nanjing, China
Ningbo Second Hospital
Ningbo, China
Shanghai East Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
Hebei Provincial Tumor Hospital
Shijiazhuang, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Taizhou Hospital of Zhejiang Province
Taizhou, China
Tianjin Cancer Hospital
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, China
Northern Jiangsu People's Hospital
Yangzhou, China
Henan Cancer Hospital
Zhengzhou, China
Sjællands Universitetshospital
Roskilde, Denmark
Hopital Louis Pradel
Bron, France
HOP Nord
Marseille, France
HOP Nord Laennec
Nantes, France
HOP Tenon - One AP-HP
Paris, France
HOP Pontchaillou
Rennes, France
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, France
Hôpital Larrey - CHU de Toulouse
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Köln (AöR)
Cologne, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Varisano LungenZentrum (VLZ)
Frankfurt, Germany
Asklepios Fachkliniken München-Gauting
Gauting, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany
Pius-Hospital, Oldenburg
Oldenburg, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, Germany