Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small C… (NCT07486817) | Clinical Trial Compass
RecruitingPhase 2
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
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. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years.
Pembrolizumab is given every 3 weeks for up to 2 years.
This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
. Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status
. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease
. Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial focused on how well zongertinib is tolerated when combined with chemotherapy or chemotherapy plus pembrolizumab — given that the main thing being measured is whether patients have to stop or pause zongertinib in the first two cycles due to side effects, what are the most common side effects my doctor would be watching for, and how would they manage them?
2Since this trial is specifically for non-squamous non-small cell lung cancer with HER2 mutations, can my doctor confirm whether my tumor's HER2 mutation type and my cancer's current stage would even make me a reasonable candidate to discuss with the trial team?
3The study is testing zongertinib in combination with chemotherapy, with or without the immunotherapy drug pembrolizumab — how would my doctor decide which combination arm might be more relevant to my situation, and what additional risks come with adding pembrolizumab?
4Are there already approved or standard treatment options for HER2-mutated non-small cell lung cancer that my doctor would recommend I consider before or instead of a Phase 2 trial like this one?
5Given that the trial is still in Phase 2 and actively recruiting, what does my doctor think we currently don't know about zongertinib's safety profile in combination with chemotherapy, and how does that uncertainty compare to what's already established for other HER2-targeted treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment
. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information
. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply.
Exclusion criteria
. Tumors with targetable alterations with approved available therapy
. Presence or history of leptomeningeal disease
. 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
. 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
. Previous therapy with a HER2-directed agent
. 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.