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Search / Trial NCT06151574

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported