Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Beamion LUNG 2: A Phase III, Open-label, Randomized, Active-controlled, Multi-centre Trial Evaluating Orally Administered Zongertinib (BI 1810631) Compared With Standard of Care as First-line Treatment in Patients With Unresectable, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harbouring HER2 Tyrosine Kinase Domain Mutations
3 other identifiers
interventional
416
25 countries
157
Brief Summary
This study is open to adults 18 years and older with advanced or metastatic non-small cell lung cancer. People can join the study if they have tumours with HER2 mutations and have not yet received any systemic therapy including chemotherapy for advanced or metastatic lung cancer. The purpose of this study is to find out whether a medicine called zongertinib (BI 1810631) can slow down the worsening of advanced non-small cell lung cancer better than the standard treatment available. Zongertinib may slow cancer cell growth by inhibiting HER2. This would prolong cancer re-occurrence and increase survival. Current standard treatment is pembrolizumab plus platinum-pemetrexed chemotherapy. Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein. Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2024
Typical duration for phase_3
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedStudy Start
First participant enrolled
February 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 28, 2028
April 15, 2026
April 1, 2026
2.6 years
November 22, 2023
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 determined by blinded central independent review
PFS is defined as the time from randomization until tumor progression according to RECIST 1.1 or death from any cause, whichever occurs earlier.
up to 4 years and 5 months
Secondary Outcomes (15)
Key secondary endpoint: Overall Response (OR) according to RECIST 1.1 determined by blinded central independent review
up to 53 months
Key secondary endpoint: Change from baseline to Week 25 of Non-small cell lung cancer Symptom Assessment Questionnaire (NSCLC-SAQ) total score
at baseline, at week 25
Key secondary endpoint: Overall Survival (OS)
up to 53 months
Duration of response (DoR), determined by blinded central independent review
up to 53 months
PFS determined by blinded central independent review
up to 53 months
- +10 more secondary outcomes
Study Arms (2)
Experimental treatment arm
EXPERIMENTALzongertinib only
Comparator arm
ACTIVE COMPARATORpembrolizumab plus platinum-pemetrexed chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent form (ICF) in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
- Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
- Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
- Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
- Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
You may not qualify if:
- Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except;
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment
- Tumors with targetable alterations with approved available therapy.
- Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement.
- Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
- History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
- Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (162)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Pioneer Research Center - Bullhead City
Bullhead City, Arizona, 86442, United States
Precision NextGen Oncology
Beverly Hills, California, 90212, United States
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, 93710, United States
OPN Healthcare, Inc.
Glendale, California, 91203, United States
Scripps Green Hospital
La Jolla, California, 92037, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
Oncology Hematology Associates
Springfield, Missouri, 65807, United States
Cancer Care Specialists
Reno, Nevada, 89511, United States
Northwell Health
Lake Success, New York, 11042, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Regional Medical Oncology Center
Wilson, North Carolina, 27893, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Carolina Blood and Cancer Care Associates, PA
Rock Hill, South Carolina, 29732, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Swedish Cancer Institute
Edmonds, Washington, 98026, United States
Swedish Cancer Institute
Issaquah, Washington, 98029, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Clinica Adventista Belgrano
CABA, 1430, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autónoma de Bs As, C1426ANZ, Argentina
Instituto Oncologico de Cordoba
Córdoba, X5000, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, S2000DEJ, Argentina
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Krems University Hospital
Krems, 3500, Austria
Clinic Floridsdorf
Vienna, 1210, Austria
Brussels - HOSP Jules Bordet
Anderlecht, 1070, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Associacao Dr. Bartholomeu Tacchini
Bento Gonçalves, 95700-084, Brazil
Hospital do Cancer de Londrina
Londrina, 86015-520, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
OncoClinicas Rio de Janeiro
Rio de Janeiro, 22250-040, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, 09060-650, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, 15090-000, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000, Brazil
Bradford Hill- Centro de Investigación Clínica
Recoleta, 8420383, Chile
Cancer Hospital of Chinese Academy of Medical Science
Beijing, 1000021, China
Beijing Cancer Hospital
Beijing, 100142, China
West China Hospital, Sichuan University
Chengdu, 610042, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317099, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Union Hospital
Wuhan, 430022, China
First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Hôpital Louis Pradel
Bron, 69677, France
CTR Leon Berard
Lyon, 69373, France
HOP Nord
Marseille, 13015, France
HOP Tenon
Paris, 75020, France
INS Curie
Paris, 75248, France
HOP Pontchaillou
Rennes, 35000, France
HOP Civil
Strasbourg, 67091, France
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Gemeinschaftskrankenhaus Havelhöhe gGmbH
Berlin, 14089, Germany
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Justus-Liebig Universität Gießen
Giessen, 35392, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Pius-Hospital, Oldenburg
Oldenburg, 26121, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, 51727, Hong Kong
Princess Margaret Hospital
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, 999077, Hong Kong
Rambam Medical Center
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center Beilinson
Petah Tikva, 49100, Israel
Sourasky Medical Center
Tel Aviv, 6423906, Israel
Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Istituto Di Candiolo
Candiolo (TO), 10060, Italy
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Catania, 95123, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131, Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, 43100, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
A. O. Ospedale Circolo Fond. Macchi
Varese, 21100, Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681, Japan
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563, Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577, Japan
Shikoku Cancer Center
Ehime, Matsuyama, 791-0280, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hakodate Goryoukaku Hospital
Hokkaido, Hakodate, 040-8611, Japan
Hokkaido Cancer Center
Hokkaido, Sapporo, 003-0804, Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, 920-8641, Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511, Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Tohoku University Hospital
Miyagi, Sendai, 980-8574, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
Komagome Hospital
Tokyo, Bunkyo-ku, 113-8677, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
FAICIC S de RL de C.V.
Veracruz, 91900, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066 CX, Netherlands
Maastricht University Medisch Centrum
Maastricht, 6229 HX, Netherlands
Vestre Viken HF, Drammen Sykehus
Drammen, N-3004, Norway
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, 0379, Norway
Polish Mother's Memorial Hospital - Research Institute
Lodz, 93-338, Poland
Greater Poland Center of Pulmonology and Thoracic Surgery
Poznan, 60-569, Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Poznan, 60693, Poland
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, 02-781, Poland
Hospital CUF Tejo
Lisbon, 1350-352, Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
Pan American Center for Oncology Trials, LLC
Rio Piedras, 00935, Puerto Rico
National University Hospital-Singapore-22806
Singapore, 119228, Singapore
National Cancer Centre Singapore
Singapore, 168583, Singapore
Chungbuk National University Hospital
Cheongiu, 28644, South Korea
National Cancer Center
Goyang, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Santa Creu i Sant Pau
Barcelona, 08026, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital General Universitario Gregorio Marañón
Madrid, 28009, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Málaga
Málaga, 29010, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 45, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Chung Shan Medical University Hospital
Taichung, 404, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
National Taiwan University Cancer Center
Taipei, 106, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, 330, Taiwan
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
The Royal Marsden Hospital, London
London, SW3 6JJ, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2023
First Posted
November 30, 2023
Study Start
February 9, 2024
Primary Completion (Estimated)
September 2, 2026
Study Completion (Estimated)
January 28, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.