Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Start Date
1/16/2026
Completion Date
9/2/2036
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.
Detailed Description
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 Criteria
Age Range: 18 years to No maximum
Interventions
Zongertinib
Pembrolizumab
Atezolizumab
Durvalumab
Nivolumab
Conditions
Locations
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California 93710
United States
OPN Healthcare, Inc.
Glendale, California 91203
United States
University of California Irvine
Irvine, California 92697
United States
Sutter Health
Roseville, California 95661
United States
University of California San Francisco
San Francisco, California 94143
United States
Sarcoma Oncology Center
Santa Monica, California 90403
United States
University of California Los Angeles
Santa Monica, California 90404
United States
Northern California Kaiser Permanente
Vallejo, California 94589
United States
George Washington University Cancer Center
Washington D.C., District of Columbia 20037
United States
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United States
Piedmont Cancer Institute
Atlanta, Georgia 30318
United States
Northwest Georgia Oncology Centers
Marietta, Georgia 30060
United States
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho 83706
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois 60612
United States
Duly Health and Care - Lisle
Lisle, Illinois 60532
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Cancer Care Specialists
Reno, Nevada 89511
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Durham VA Health Care System
Durham, North Carolina 27705
United States
Providence Cancer Institute
Portland, Oregon 97213
United States
Providence Cancer Institute
Portland, Oregon 97225
United States
Hendrick Health
Abilene, Texas 79601
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Community Cancer Trials of Utah
Ogden, Utah 84405
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación)
CABA, 1185
Argentina
Hospital Britanico de Buenos Aires
CABA, 1280AEB
Argentina
Centro Oncologico Korben
CABA, 1426
Argentina
Clinica Adventista Belgrano
CABA, 1430
Argentina
Instituto Medico Especializado Alexander Fleming
Capital Federal, C1426ANZ
Argentina
Royal North Shore Hospital
Sydney, New South Wales 2065
Australia
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Australia
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
Australia
Medical University of Innsbruck
Innsbruck, A-6020
Austria
Clinic Floridsdorf
Vienna, 1210
Austria
Edegem - UNIV UZ Antwerpen
Edegem, 2650
Belgium
UZ Leuven
Leuven, 3000
Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000
Belgium
Hospital de Amor
Barretos, 14784-400
Brazil
NewData Clinical Research - Maceió
Maceió, 57020-360
Brazil
Centro de Pesquisa Oncology Natal
Natal, 59020-400
Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, 90110-270
Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, 09060-650
Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000
Brazil
A.C. Camargo
São Paulo, 01509-010
Brazil
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta T6G 1Z2
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Centro de Estudios Clinicos SAGA
Providencia, 7500653
Chile
Bradford Hill- Centro de Investigación Clínica
Recoleta, 8420383
Chile
China-Japan Friendship Hospital
Beijing, 100029
China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
China
The First Hospital of Jilin University
Changchun, 130000
China
Xiangya Hospital, Central South University
Changsha, 410008
China
Hunan Province Tumor Hospital
Changsha, 410013
China
Sichuan Cancer Hospital
Chengdu, 610041
China
West China Hospital, Sichuan University
Chengdu, 610041
China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080
China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
China
Zhejiang Cancer Hospital
Hangzhou, 310022
China
Harbin Medical University Cancer Hospital
Harbin, 150081
China
Shandong Cancer Hospital
Jinan, 250117
China
Yunnan Provincial Tumor Hospital
Kunming, 650118
China
Linyi Cancer Hospital
Linyi, 276034
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
China
Nanjing Drum Tower Hospital
Nanjing, 210008
China
Ningbo Second Hospital
Ningbo, 315010
China
Shanghai East Hospital
Shanghai, 200121
China
Shanghai Pulmonary Hospital
Shanghai, 200433
China
Hebei Provincial Tumor Hospital
Shijiazhuang, 50035
China
The First Affiliated Hospital of Soochow University
Suzhou, 215006
China
Taizhou Hospital of Zhejiang Province
Taizhou, 317099
China
Tianjin Cancer Hospital
Tianjin, 300060
China
Tianjin Medical University General Hospital
Tianjin, 30052
China
Wuhan Union Hospital
Wuhan, 430056
China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221009
China
Northern Jiangsu People's Hospital
Yangzhou, 225001
China
Henan Cancer Hospital
Zhengzhou, 450008
China
Sjællands Universitetshospital
Roskilde, 4000
Denmark
Hôpital Louis Pradel
Bron, 69677
France
HOP Nord
Marseille, 13915
France
HOP Nord Laennec
Nantes, 44093
France
HOP Tenon - One AP-HP
Paris, 75970
France
HOP Pontchaillou
Rennes, 35033
France
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, 67200
France
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
France
Institut Gustave Roussy
Villejuif, 94805
France
Charité - Universitätsmedizin Berlin
Berlin, 12203
Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937
Germany
Klinikum Esslingen
Esslingen am Neckar, 73730
Germany
Varisano LungenZentrum (VLZ)
Frankfurt, 65929
Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Germany
Pius-Hospital, Oldenburg
Oldenburg, 26121
Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Germany
Henry Dunant Hospital, Athens
Athens, 11526
Greece
Chest Hospital of Athens "Sotiria"
Athens, 11527
Greece
University General Hospital Attikon
Athens, 12462
Greece
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, 51727
Hong Kong
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077
Hong Kong
Princess Margaret Hospital
Hong Kong, 999077
Hong Kong
Queen Mary Hospital
Hong Kong,
Hong Kong
Rambam Health Care Campus
Haifa, 3109601
Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, 9103102
Israel
Meir Medical Center
Kfar Saba, 44281
Israel
Sheba Medical Center
Ramat Gan, 5262000
Israel
Sourasky Medical Center
Tel Aviv, 6093246
Israel
Istituto Tumori Giovanni Paolo II
Bari, 70124
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), 95045
Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Italy
AOU San Luigi Gonzaga
Orbassano (TO), 10043
Italy
Istituti Fisioterapici Ospitalieri
Roma, 144
Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089
Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Japan
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Japan
Hokkaido Cancer Center
Hokkaido, Sapporo, 003-0804
Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Japan
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914
Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Japan
Okayama University Hospital
Okayama, Okayama, 700-8558
Japan
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Japan
Kindai University Hospital
Osaka, Sakai, 590-0197
Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Japan
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298
Japan
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806
Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498
Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Japan
Centro Oncologico Internacional
Jalisco, 45640
Mexico
Centro de Infusion Profesional Integral (CIPI)
Mexico City, 14210
Mexico
Instituto Nacional de Cancerologia
México, 14080
Mexico
Centro Oncologico Personalizado
México, 6760
Mexico
Centro Medico Zambrano Hellion
Monterrey, 66278
Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX
Netherlands
Hospital CUF Tejo
Lisbon, 1350-352
Portugal
Hospital da Luz
Lisbon, 1500-650
Portugal
Hospital CUF Porto
Porto, 4100-180
Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072
Portugal
Lotus Med
Bucharest, 12292
Romania
Memorial Healthcare International
Bucharest, 13823
Romania
Ovidius Clinical Hospital S.R.L
Ovidiu, 905900
Romania
Polaris Medical S.A.
Suceagu/ Cluj Napoca, 407062
Romania
National Cancer Centre Singapore
Singapore, 168583
Singapore
National Cancer Center
Goyang, 10408
South Korea
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
Seoul National University Hospital
Seoul, 3080
South Korea
Severance Hospital
Seoul, 3722
South Korea
Asan Medical Center
Seoul, 5505
South Korea
Samsung Medical Center
Seoul, 6351
South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247
South Korea
Ajou University Hospital
Suwon, 16499
South Korea
Hospital del Mar
Barcelona, 8003
Spain
Hospital Universitari Vall D Hebron
Barcelona, 8035
Spain
Hospital Universitario De Burgos
Burgos, 9006
Spain
Hospital General Universitario de Elche
Elche, 3203
Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407
Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 8908
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Puerta de Hierro
Majadahonda, 28222
Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Spain
Complejo Hospitalario de Navarra
Pamplona, 31008
Spain
Salut Sant Joan de Reus
Reus, 43204
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 46
Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
National Taiwan University Hospital
Taipei, 10048
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Tri-Service General Hospital
Taipei, 114
Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Taiwan
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 6018
Turkey (Türkiye)
Medeniyet University
Istanbul, 34862
Turkey (Türkiye)
Velindre Cancer Centre
Cardiff, CF14 2TL
United Kingdom
Western General Hospital
Edinburgh, EH4 2XU
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
United Kingdom
The Christie
Manchester, M20 4BX
United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
United Kingdom