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Clinical Trials in the UK / NCT06151574
Active, not recruiting Phase 3

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

NCT06151574 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2024-02-09
Last updated
2026-08-20

Condition(s) studied

Lung Cancer, Non-squamous, Non-small Cell

Investigational drug(s) / intervention(s)

zongertinibpembrolizumabcisplatincarboplatinpemetrexed

zongertinib: zongertinib

pembrolizumab: pembrolizumab

cisplatin: platinum-pemetrexed chemotherapy

carboplatin: platinum-pemetrexed chemotherapy

pemetrexed: platinum-pemetrexed chemotherapy

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (163)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama
Pioneer Research Center - Bullhead City Bullhead City Arizona
Precision NextGen Oncology Beverly Hills California
ClinRé 001-022 (Premier Cancer Care and Infusion Center) Fresno California
OPN Healthcare, Inc. Glendale California
Scripps Green Hospital La Jolla California
Valkyrie Clinical Trials Los Angeles California
Sharp Memorial Hospital San Diego California
St. Louis Cancer Care, LLP Bridgeton Missouri
Oncology Hematology Associates Springfield Missouri
Cancer Care Specialists Reno Nevada
Northwell Health Lake Success New York
Montefiore Medical Center The Bronx New York
Regional Medical Oncology Center Wilson North Carolina
Gabrail Cancer Center Canton Ohio
Carolina Blood and Cancer Care Associates, PA Rock Hill South Carolina
SCRI Oncology Partners Nashville Tennessee
Huntsman Cancer Institute Salt Lake City Utah
Virginia Cancer Specialists, PC Fairfax Virginia
Swedish Cancer Institute Edmonds Washington
Swedish Cancer Institute Issaquah Washington
Swedish Cancer Institute Seattle Washington
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 Médico de la Fundación Estudios Clínicos Rosario Argentina
Prince of Wales Hospital-Randwick-66496 Randwick New South Wales
Royal North Shore Hospital-St Leonards-20807 St Leonards New South Wales
Princess Alexandra Hospital Woolloongabba Queensland
Austin Health Heidelberg Victoria
St John of God Subiaco Hospital Subiaco Western 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

+ 123 more sites — see the full list on the official registry below.

On this site

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More Boehringer Ingelheim trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06151574 on ClinicalTrials.gov ↗ ← All trials in the UK