Last updated 3 days ago
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
270 patients around the world
Available in Argentina, Mexico
Boehringer Ingelheim
8Research sites
270Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.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.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.
- Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, exceptEffectively treated non-melanoma skin cancers.Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except for effectively treated carcinoma in situ of the cervix.Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except for effectively treated ductal carcinoma in situ.Previous or concomitant malignancies other than the one treated in this trial within the last 5 years, except for 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.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.
Sites
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Clínica Adventista Belgrano - CABA - Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Health Pharma Professional Research
Recruiting
Instituto Nacional de Cancerología - Ciudad de México
StudyBeamion LUNG 2
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06151574
