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
Launched by BOEHRINGER INGELHEIM · Nov 22, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The Beamion LUNG-2 trial is studying a new medication called zongertinib (BI 1810631) to see if it can help people with advanced non-small cell lung cancer that has a specific type of genetic mutation known as HER2. This study is for adults aged 18 and older who have not yet received any treatment for their cancer, including chemotherapy. The goal is to find out if zongertinib can slow down the progression of cancer more effectively than the current standard treatment, which includes a combination of pembrolizumab (a type of immunotherapy) and chemotherapy.
If you join the trial, you will be randomly assigned to one of two groups: one will receive zongertinib, and the other will receive the standard treatment. You’ll visit the study site every three weeks for check-ups and tests, including scans to monitor your tumor. The study may last up to 70 months, and during this time, doctors will keep track of your health and any side effects you may experience. To participate, you need to have a confirmed diagnosis of advanced non-small cell lung cancer with a HER2 mutation and meet other specific health criteria. This trial offers a chance to access a potentially beneficial treatment while contributing to important research.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • 1. 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.
- • 2. 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.
- • 3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
- • 4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
- • 5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
- • 6. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
- • 7. 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.
- • 8. 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.
- • Further inclusion criteria apply.
- Exclusion criteria:
- • 1. 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
- • 2. Tumors with targetable alterations with approved available therapy.
- • 3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
- • 4. 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.
- • 5. 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.
- • 6. 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.
- • 7. 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.
- • 8. 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.
- • Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Seattle, Washington, United States
Parma, , Italy
Salt Lake City, Utah, United States
Madrid, , Spain
Hong Kong, , Hong Kong
San Diego, California, United States
Bronx, New York, United States
London, , United Kingdom
Barcelona, , Spain
Madrid, , Spain
Budapest, , Hungary
Porto Alegre, , Brazil
Canton, Ohio, United States
La Jolla, California, United States
Woolloongabba, Queensland, Australia
Taipei, , Taiwan
Huntsville, Alabama, United States
Greenville, North Carolina, United States
Tianjin, , China
Alicante, , Spain
St Leonards, New South Wales, Australia
Madrid, , Spain
Valencia, , Spain
Heidelberg, Victoria, Australia
Alicante, , Spain
Bilbao, , Spain
Dresden, , Germany
Seoul, , Korea, Republic Of
Leicester, , United Kingdom
Edinburgh, , United Kingdom
Tübingen, , Germany
Fairfax, Virginia, United States
Leuven, , Belgium
Barcelona, , Spain
Sevilla, , Spain
Stockholm, , Sweden
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Woolloongabba, , Australia
Wuhan, , China
Beijing, , China
Fuzhou, , China
Shanghai, , China
Vancouver, British Columbia, Canada
Hangzhou, , China
Hong Kong, , Hong Kong
Harbin, , China
Incheon, , Korea, Republic Of
Toronto, Ontario, Canada
Oldenburg, , Germany
La Rioja, , Argentina
Seoul, , Korea, Republic Of
Gent, , Belgium
Aichi, Nagoya, , Japan
Chiba, Kashiwa, , Japan
Ishikawa, Kanazawa, , Japan
Okayama, Okayama, , Japan
Shizuoka, Sunto Gun, , Japan
Singapore, , Singapore
Málaga, , Spain
Shanghai, , China
Guangzhou, , China
Tokyo, Chuo Ku, , Japan
Köln, , Germany
Bridgeton, Missouri, United States
Zhengzhou, , China
Göteborg, , Sweden
Barcelona, , Spain
Haifa, , Israel
Lyon, , France
Xiamen, , China
Hong Kong, , Hong Kong
Kaohsiung, , Taiwan
Taoyuan, , Taiwan
Madrid, , Spain
Strasbourg, , France
Villejuif, , France
Mexico, , Mexico
A Coruña, , Spain
Chengdu, , China
Marseille, , France
Miyagi, Sendai, , Japan
Seoul, , Korea, Republic Of
Varese, , Italy
Augsburg, , Germany
Fukuoka, Fukuoka, , Japan
Heidelberg, , Australia
Szekesfehervar, , Hungary
Bari, , Italy
Napoli, , Italy
Napoli, , Italy
Lisboa, , Portugal
L'hospitalet De Llobregat, , Spain
Goyang, , Korea, Republic Of
Montreal, Quebec, Canada
Kfar Saba, , Israel
Tel Aviv, , Israel
Porto, , Portugal
Ciudad Autónoma De Bs As, , Argentina
Heidelberg, , Germany
Petach Tikva, , Israel
Tokyo, Bunkyo Ku, , Japan
Solna, , Sweden
Subiaco, Western Australia, Australia
Paris, , France
Lisboa, , Portugal
San Diego, California, United States
Toronto, , Canada
Drammen, , Norway
Lake Success, New York, United States
Maastricht, , Netherlands
Aomori, Hirosaki, , Japan
Santo André, , Brazil
Farkasgyepu, , Hungary
São José Do Rio Preto, , Brazil
Wilson, North Carolina, United States
Anderlecht, , Belgium
Edmonds, Washington, United States
Issaquah, Washington, United States
Rennes, , France
Bron, , France
Reno, Nevada, United States
Mar Del Plata, , Argentina
Roma, , Italy
Rosario, , Argentina
Rock Hill, South Carolina, United States
Kanagawa, Kawasaki, , Japan
Wenzhou, , China
Shanghai, , China
Springfield, Missouri, United States
Kanagawa, Yokohama, , Japan
Tokyo, Koto Ku, , Japan
Lodz, , Poland
Subiaco, , Australia
Hangzhou, , China
Los Angeles, California, United States
Kyoto, Kyoto, , Japan
Rio Piedras, , Puerto Rico
Viedma, , Argentina
Londrina, , Brazil
Taipei, , Taiwan
Ciudad De Mexico, , Mexico
Cheongiu, , Korea, Republic Of
Lisboa, , Portugal
Ehime, Matsuyama, , Japan
Osaka, Osaka, , Japan
Berlin, , Germany
Krems An Der Donau, , Austria
Veracruz, , Mexico
Candiolo (To), , Italy
Haerbin, , China
Vienna, , Austria
Hong Kong, , Hong Kong
Toulouse, , France
Wakayama, Wakayama, , Japan
Singapore, , Singapore
Hangzhou, , China
Glendale, California, United States
London, , United Kingdom
Sutton, , United Kingdom
Krems, , Austria
Budapest, , Hungary
Beverly Hills, California, United States
Rennes, , France
Roma, , Italy
Paris, , France
Petach Tikva, , Israel
Hong Kong, , Hong Kong
Nashville, Tennessee, United States
Gießen, , Germany
Canton, Ohio, United States
Drammen, , Norway
Taizhou, , China
Hokkaido, Hakodate, , Japan
Warsaw, , Poland
Hokkaido, Sapporo, , Japan
Suwon, , Korea, Republic Of
Taichung, , Taiwan
Beijing, , China
Recoleta, , Chile
Poznan, , Poland
Poznan, , Poland
Bento Goncalves, , Brazil
Sao Paulo, , Brazil
Mexico, , Mexico
Lisboa, , Portugal
Rio De Janeiro, , Brazil
Hong Kong, , Hong Kong
Bullhead City, Arizona, United States
Gießen, , Germany
Amsterdam, , Netherlands
Oslo, , Norway
Tokyo, Bunkyo Ku, , Japan
Randwick, New South Wales, Australia
La Jolla, California, United States
Caba, , Argentina
Córdoba, , Argentina
St Leonards, New South Wales, Australia
Marseille, , France
Deszk, , Hungary
Catania, , Italy
Singapore, , Singapore
Rio Piedras, , Puerto Rico
Irving, Texas, United States
Randwick, , Australia
St Leonards, , Australia
Sao Paulo, , Brazil
Montreal, , Canada
Vancouver, , Canada
Toulouse, , France
Leicester, , United Kingdom
Randwick, New South Wales, Australia
Oslo, , Norway
Barcelona, , Spain
Oslo, , Norway
Parma, , Italy
Fresno, California, United States
Hong Kong, , Hong Kong
Chengdu, , China
Caba, , Argentina
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported