Actively Recruiting
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Led by Boehringer Ingelheim · Updated on 2026-05-06
400
Participants Needed
197
Research Sites
554 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before joining the trial
- Age 18 years or older or over legal age of consent in your country
- Male or female; women able to use two effective birth control methods if of childbearing potential
- Documented activating HER2 tyrosine kinase domain mutation
- Confirmed diagnosis of primary non-small cell lung cancer
- Archival tumor tissue sample submitted for HER2 confirmation
- Cancer staged no higher than Stage IIIB before treatment
- ECOG performance status of 0 or 1
- Adequate organ function based on lab tests
- Additional inclusion criteria apply
You will not qualify if you...
- NSCLC with mixed histology or positive neuroendocrine markers
- Major surgery within 4 weeks before randomization
- Radiation therapy for primary NSCLC
- Co-occurring actionable mutations with approved targeted therapy (e.g., EGFR, ALK)
- Use of investigational drugs within 5 half-lives prior to study
- History or presence of active or past non-infectious interstitial lung disease or pneumonitis
- Active infectious disease requiring systemic treatment
- Uncontrolled gastrointestinal disorders affecting drug absorption
- Previous or other cancers within last 3 years except certain treated cancers
- Significant or uncontrolled heart problems, QTcF >470 msec, or ejection fraction <50%
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 197 locations
1
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, United States, 93710
Actively Recruiting
2
OPN Healthcare, Inc.
Glendale, California, United States, 91203
Actively Recruiting
3
University of California Irvine
Irvine, California, United States, 92697
Not Yet Recruiting
4
Sutter Health
Roseville, California, United States, 95661
Not Yet Recruiting
5
University of California San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
6
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Not Yet Recruiting
7
University of California Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
8
Northern California Kaiser Permanente
Vallejo, California, United States, 94589
Not Yet Recruiting
9
George Washington University Cancer Center
Washington D.C., District of Columbia, United States, 20037
Not Yet Recruiting
10
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
11
Piedmont Cancer Institute
Atlanta, Georgia, United States, 30318
Actively Recruiting
12
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
Actively Recruiting
13
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, United States, 83706
Not Yet Recruiting
14
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
15
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612
Actively Recruiting
16
Duly Health and Care - Lisle
Lisle, Illinois, United States, 60532
Not Yet Recruiting
17
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
18
Cancer Care Specialists
Reno, Nevada, United States, 89511
Actively Recruiting
19
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
20
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
21
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
22
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
23
Durham VA Health Care System
Durham, North Carolina, United States, 27705
Not Yet Recruiting
24
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
25
Hendrick Health
Abilene, Texas, United States, 79601
Actively Recruiting
26
Community Cancer Trials of Utah
Ogden, Utah, United States, 84405
Actively Recruiting
27
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
28
Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación)
CABA, Argentina, 1185
Actively Recruiting
29
Hospital Britanico de Buenos Aires
CABA, Argentina, 1280AEB
Actively Recruiting
30
Centro Oncologico Korben
CABA, Argentina, 1426
Actively Recruiting
31
Clinica Adventista Belgrano
CABA, Argentina, 1430
Actively Recruiting
32
Instituto Medico Especializado Alexander Fleming
Capital Federal, Argentina, C1426ANZ
Not Yet Recruiting
33
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Not Yet Recruiting
34
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Not Yet Recruiting
35
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Not Yet Recruiting
36
Austin Health
Heidelberg, Victoria, Australia, 3084
Not Yet Recruiting
37
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
38
Medical University of Innsbruck
Innsbruck, Austria, A-6020
Not Yet Recruiting
39
Clinic Floridsdorf
Vienna, Austria, 1210
Not Yet Recruiting
40
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
41
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
42
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000
Not Yet Recruiting
43
Hospital de Amor
Barretos, Brazil, 14784-400
Actively Recruiting
44
NewData Clinical Research - Maceió
Maceió, Brazil, 57020-360
Not Yet Recruiting
45
Centro de Pesquisa Oncology Natal
Natal, Brazil, 59020-400
Actively Recruiting
46
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, Brazil, 90110-270
Not Yet Recruiting
47
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, Brazil, 09060-650
Actively Recruiting
48
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil, 01246-000
Not Yet Recruiting
49
A.C. Camargo
São Paulo, Brazil, 01509-010
Not Yet Recruiting
50
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z2
Not Yet Recruiting
51
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
52
Centro de Estudios Clinicos SAGA
Providencia, Chile, 7500653
Not Yet Recruiting
53
Bradford Hill- Centro de Investigación Clínica
Recoleta, Chile, 8420383
Not Yet Recruiting
54
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
55
Beijing Chest Hospital, Capital Medical University
Beijing, China, 101149
Actively Recruiting
56
The First Hospital of Jilin University
Changchun, China, 130000
Actively Recruiting
57
Xiangya Hospital, Central South University
Changsha, China, 410008
Not Yet Recruiting
58
Hunan Province Tumor Hospital
Changsha, China, 410013
Not Yet Recruiting
59
Sichuan Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
60
West China Hospital, Sichuan University
Chengdu, China, 610041
Not Yet Recruiting
61
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, China, 510080
Actively Recruiting
62
The First Affiliated Hospital, Zhejiang University
Hangzhou, China, 310003
Not Yet Recruiting
63
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Not Yet Recruiting
64
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Actively Recruiting
65
Shandong Cancer Hospital
Jinan, China, 250117
Actively Recruiting
66
Yunnan Provincial Tumor Hospital
Kunming, China, 650118
Not Yet Recruiting
67
Linyi Cancer Hospital
Linyi, China, 276034
Not Yet Recruiting
68
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
69
Nanjing Drum Tower Hospital
Nanjing, China, 210008
Actively Recruiting
70
Ningbo Second Hospital
Ningbo, China, 315010
Actively Recruiting
71
Shanghai East Hospital
Shanghai, China, 200121
Actively Recruiting
72
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
73
Hebei Provincial Tumor Hospital
Shijiazhuang, China, 050035
Not Yet Recruiting
74
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Actively Recruiting
75
Taizhou Hospital of Zhejiang Province
Taizhou, China, 317099
Actively Recruiting
76
Tianjin Cancer Hospital
Tianjin, China, 300060
Actively Recruiting
77
Tianjin Medical University General Hospital
Tianjin, China, 30052
Actively Recruiting
78
Wuhan Union Hospital
Wuhan, China, 430056
Actively Recruiting
79
Affiliated Hospital, Xuzhou Medical college
Xuzhou, China, 221009
Actively Recruiting
80
Northern Jiangsu People's Hospital
Yangzhou, China, 225001
Actively Recruiting
81
Henan Cancer Hospital
Zhengzhou, China, 450008
Not Yet Recruiting
82
Sjællands Universitetshospital
Roskilde, Denmark, 4000
Not Yet Recruiting
83
Hôpital Louis Pradel
Bron, France, 69677
Actively Recruiting
84
HOP Nord
Marseille, France, 13915
Actively Recruiting
85
HOP Nord Laennec
Nantes, France, 44093
Actively Recruiting
86
HOP Tenon - One AP-HP
Paris, France, 75970
Not Yet Recruiting
87
HOP Pontchaillou
Rennes, France, 35033
Actively Recruiting
88
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, France, 67200
Not Yet Recruiting
89
Hôpital Larrey - CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
90
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
91
Universitätsklinikum Köln (AöR)
Cologne, Germany, 50937
Not Yet Recruiting
92
Klinikum Esslingen
Esslingen am Neckar, Germany, 73730
Actively Recruiting
93
Varisano LungenZentrum (VLZ)
Frankfurt, Germany, 65929
Not Yet Recruiting
94
Asklepios Fachkliniken München-Gauting
Gauting, Germany, 82131
Not Yet Recruiting
95
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Actively Recruiting
96
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
Not Yet Recruiting
97
Pius-Hospital, Oldenburg
Oldenburg, Germany, 26121
Actively Recruiting
98
Universitätsklinikum Würzburg AÖR
Würzburg, Germany, 97078
Not Yet Recruiting
99
Henry Dunant Hospital, Athens
Athens, Greece, 11526
Not Yet Recruiting
100
Chest Hospital of Athens "Sotiria"
Athens, Greece, 11527
Not Yet Recruiting
101
University General Hospital Attikon
Athens, Greece, 12462
Not Yet Recruiting
102
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, Hong Kong, 51727
Not Yet Recruiting
103
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, Hong Kong, 999077
Actively Recruiting
104
Princess Margaret Hospital
Hong Kong, Hong Kong, 999077
Not Yet Recruiting
105
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
106
Rambam Health Care Campus
Haifa, Israel, 3109601
Not Yet Recruiting
107
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, Israel, 9103102
Not Yet Recruiting
108
Meir Medical Center
Kfar Saba, Israel, 44281
Not Yet Recruiting
109
Sheba Medical Center
Ramat Gan, Israel, 5262000
Not Yet Recruiting
110
Sourasky Medical Center
Tel Aviv, Israel, 6093246
Not Yet Recruiting
111
Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Not Yet Recruiting
112
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133
Not Yet Recruiting
113
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), Italy, 95045
Not Yet Recruiting
114
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, Italy, 80131
Actively Recruiting
115
AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Not Yet Recruiting
116
Istituti Fisioterapici Ospitalieri
Roma, Italy, 00144
Actively Recruiting
117
Istituto Clinico Humanitas
Rozzano (MI), Italy, 20089
Not Yet Recruiting
118
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Not Yet Recruiting
119
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Actively Recruiting
120
Fujita Health University Hospital
Aichi, Toyoake, Japan, 470-1192
Actively Recruiting
121
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Not Yet Recruiting
122
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
123
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, Japan, 807-8556
Actively Recruiting
124
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan, 734-8551
Actively Recruiting
125
Hokkaido Cancer Center
Hokkaido, Sapporo, Japan, 003-0804
Actively Recruiting
126
Kitasato University Hospital
Kanagawa, Sagamihara, Japan, 252-0375
Actively Recruiting
127
Kanagawa Cancer Center
Kanagawa, Yokohama, Japan, 241-8515
Actively Recruiting
128
Sendai Kousei Hospital
Miyagi, Sendai, Japan, 981-0914
Actively Recruiting
129
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
130
Okayama University Hospital
Okayama, Okayama, Japan, 700-8558
Actively Recruiting
131
Kansai Medical University Hospital
Osaka, Hirakata, Japan, 573-1191
Not Yet Recruiting
132
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
133
Kindai University Hospital
Osaka, Sakai, Japan, 590-0197
Actively Recruiting
134
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, Japan, 591-8555
Actively Recruiting
135
Saitama Medical University International Medical Center
Saitama, Hidaka, Japan, 350-1298
Actively Recruiting
136
Saitama Cancer Center
Saitama, Kitaadachi-gun, Japan, 362-0806
Actively Recruiting
137
Shizuoka Cancer Center
Shizuoka, Sunto-gun, Japan, 411-8777
Actively Recruiting
138
Jichi Medical University Hospital
Tochigi, Shimotsuke, Japan, 329-0498
Not Yet Recruiting
139
Juntendo University Hospital
Tokyo, Bunkyo-ku, Japan, 113-8431
Not Yet Recruiting
140
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Not Yet Recruiting
141
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
142
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, Japan, 160-0023
Actively Recruiting
143
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
144
Centro Oncologico Internacional
Jalisco, Mexico, 45640
Not Yet Recruiting
145
Centro de Infusion Profesional Integral (CIPI)
Mexico City, Mexico, 14210
Not Yet Recruiting
146
Centro Oncologico Personalizado
México, Mexico, 06760
Not Yet Recruiting
147
Instituto Nacional de Cancerologia
México, Mexico, 14080
Not Yet Recruiting
148
Centro Medico Zambrano Hellion
Monterrey, Mexico, 66278
Not Yet Recruiting
149
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, Netherlands, 1066CX
Not Yet Recruiting
150
Hospital CUF Tejo
Lisbon, Portugal, 1350-352
Actively Recruiting
151
Hospital da Luz
Lisbon, Portugal, 1500-650
Not Yet Recruiting
152
Hospital CUF Porto
Porto, Portugal, 4100-180
Actively Recruiting
153
IPO Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Not Yet Recruiting
154
Lotus Med
Bucharest, Romania, 012292
Actively Recruiting
155
Memorial Healthcare International
Bucharest, Romania, 013823
Actively Recruiting
156
Ovidius Clinical Hospital S.R.L
Ovidiu, Romania, 905900
Actively Recruiting
157
Polaris Medical S.A.
Suceagu/ Cluj Napoca, Romania, 407062
Not Yet Recruiting
158
National Cancer Centre Singapore
Singapore, Singapore, 168583
Actively Recruiting
159
National Cancer Center
Goyang, South Korea, 10408
Not Yet Recruiting
160
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
161
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
162
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
163
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
164
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
165
The Catholic University of Korea, St.Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
166
Ajou University Hospital
Suwon, South Korea, 16499
Actively Recruiting
167
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
168
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
169
Hospital Universitario De Burgos
Burgos, Spain, 09006
Actively Recruiting
170
Hospital General Universitario de Elche
Elche, Spain, 03203
Not Yet Recruiting
171
Hospital Jerez de la Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
172
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain, 08908
Not Yet Recruiting
173
Hospital Universitario Ramon Y Cajal
Madrid, Spain, 28034
Actively Recruiting
174
Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
175
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
176
Hospital Puerta de Hierro
Majadahonda, Spain, 28222
Not Yet Recruiting
177
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
178
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Actively Recruiting
179
Salut Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
180
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
181
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
182
Sahlgrenska Universitetsjukhuset
Gothenburg, Sweden, 413 46
Actively Recruiting
183
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden, 171 76
Not Yet Recruiting
184
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
185
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
186
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
187
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
188
Tri-Service General Hospital
Taipei, Taiwan, 114
Not Yet Recruiting
189
Chang Gung Memorial Hospital, Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
190
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, Turkey (Türkiye), 06018
Not Yet Recruiting
191
Medeniyet University
Istanbul, Turkey (Türkiye), 34862
Not Yet Recruiting
192
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Not Yet Recruiting
193
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
194
Guy's Hospital
London, United Kingdom, SE1 9RT
Not Yet Recruiting
195
The Royal Marsden Hospital, Chelsea
London, United Kingdom, SW3 6JJ
Not Yet Recruiting
196
The Christie
Manchester, United Kingdom, M20 4BX
Actively Recruiting
197
The Royal Marsden Hospital, Sutton
Sutton, United Kingdom, SM2 5PT
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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