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Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab

RecruitingPhase 2Ages 18 Years - anyAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth. Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participa

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria: 1. 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 informed consent form (ICF) 2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC) 3. Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result 4. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status 5. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease 6. Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1 7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information 8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply. Exclusion criteria: 1. Tumors with targetable alterations with approved available therapy 2. Presence or history of leptomeningeal disease 3. Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start 4. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening 5. 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 6. Previous therapy with a HER2-directed agent 7. History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization Further exclusion criteria apply.
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What it tests

  • Zongertinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Pembrolizumab
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Where

17 sites
Royal North Shore Hospital
St Leonards, Australia
Cabrini Health
Malvern, Australia
Fiona Stanley Hospital
Murdoch, Australia
Guangdong Provincial People's Hospital
Guangzhou, China
Shanghai Geriatric Medical Center
Shanghai, China
CTR Leon Berard
Lyon, France
INS Curie
Paris, France
Universitätsklinikum Köln (AöR)
Cologne, Germany

…and 9 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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