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ACTIVE NOT RECRUITING

NCT06151574

PHASE3

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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. Some visits may be conducted remotely later in the study if approved by the study doctor. 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

428

Start Date

2024-02-09

Completion Date

2028-01-28

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Lung Cancer, Non-squamous, Non-small Cell

Interventions

DRUG

zongertinib

DRUG

pembrolizumab

DRUG

cisplatin

platinum-pemetrexed chemotherapy

DRUG

carboplatin

platinum-pemetrexed chemotherapy

DRUG

pemetrexed

platinum-pemetrexed chemotherapy

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.

Locations (163)

Clearview Cancer Institute

Huntsville, Alabama, United States

Pioneer Research Center - Bullhead City

Bullhead City, Arizona, United States

Precision NextGen Oncology

Beverly Hills, California, United States

ClinRé 001-022 (Premier Cancer Care and Infusion Center)

Fresno, California, United States

OPN Healthcare, Inc.

Glendale, California, United States

Scripps Green Hospital

La Jolla, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Sharp Memorial Hospital

San Diego, California, United States

St. Louis Cancer Care, LLP

Bridgeton, Missouri, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Cancer Care Specialists

Reno, Nevada, United States

Northwell Health

Lake Success, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Regional Medical Oncology Center

Wilson, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Carolina Blood and Cancer Care Associates, PA

Rock Hill, South Carolina, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Swedish Cancer Institute

Edmonds, Washington, United States

Swedish Cancer Institute

Issaquah, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Clinica Adventista Belgrano

CABA, Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autónoma de Bs As, Argentina

Instituto Oncologico de Cordoba

Córdoba, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

Prince of Wales Hospital-Randwick-66496

Randwick, New South Wales, Australia

Royal North Shore Hospital-St Leonards-20807

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Austin Health

Heidelberg, Victoria, Australia

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Krems University Hospital

Krems, Austria

Clinic Floridsdorf

Vienna, Austria

Brussels - HOSP Jules Bordet

Anderlecht, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Associacao Dr. Bartholomeu Tacchini

Bento Gonçalves, Brazil

Hospital do Câncer de Londrina

Londrina, Brazil

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

OncoClinicas Rio de Janeiro

Rio de Janeiro, Brazil

CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

Santo André, Brazil

Fundaçao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, Brazil

ICESP - Instituto do Cancer do Estado de Sao Paulo

São Paulo, Brazil

Bradford Hill- Centro de Investigacion Clinica

Recoleta, Chile

Cancer Hospital of Chinese Academy of Medical Science

Beijing, China

Beijing Cancer Hospital

Beijing, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Cancer Hospital

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Fudan University Shanghai Cancer Center

Shanghai, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Taizhou Hospital of Zhejiang Province

Taizhou, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

First Affiliated Hospital of Xiamen University

Xiamen, China

Henan Cancer Hospital

Zhengzhou, China

Hopital Louis Pradel

Bron, France

CTR Leon Berard

Lyon, France

HOP Nord

Marseille, France

HOP Tenon

Paris, France

INS Curie

Paris, France

HOP Pontchaillou

Rennes, France

HOP Civil

Strasbourg, France

Hôpital Larrey - CHU de Toulouse

Toulouse, France

Institut Gustave Roussy

Villejuif, France

Universitätsklinikum Augsburg

Augsburg, Germany

Gemeinschaftskrankenhaus Havelhöhe gGmbH

Berlin, Germany

Universitätsklinikum Köln (AöR)

Cologne, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Justus-Liebig Universität Gießen

Giessen, Germany

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

Heidelberg, Germany

Pius-Hospital, Oldenburg

Oldenburg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Queen Elizabeth Hospital-Hong Kong-51727

Hong Kong, Hong Kong

Princess Margaret Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Rambam Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center Beilinson

Petah Tikva, Israel

Sourasky Medical Center

Tel Aviv, Israel

Istituto Tumori Giovanni Paolo II

Bari, Italy

Istituto Di Candiolo

Candiolo (TO), Italy

Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania

Catania, Italy

Istituto Nazionale IRCCS Tumori Fondazione Pascale

Naples, Italy

Azienda Ospedaliera Unversitaria di Parma

Parma, Italy

AOU Policlinico Umberto I

Roma, Italy

A. O. Ospedale Circolo Fond. Macchi

Varese, Italy

Aichi Cancer Center Hospital

Aichi, Nagoya, Japan

Hirosaki University Hospital

Aomori, Hirosaki, Japan

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Shikoku Cancer Center

Ehime, Matsuyama, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Hakodate Goryoukaku Hospital

Hokkaido, Hakodate, Japan

Hokkaido Cancer Center

Hokkaido, Sapporo, Japan

Kanazawa University Hospital

Ishikawa, Kanazawa, Japan

And 63 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)