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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
EU CTIS ID: 2025-523567-38-00
What this study is testing
The primary objective of the trial is to evaluate the safety and tolerability of zongertinib together with combination partners by assessing the occurrence of discontinuation and/or prolonged interruption of zongertinib due to treatment-related AEs in the first 2 cycles of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 NSCLC
- Documented activating 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-CNS lesion according to RECIST 1.1.
You likely can't join if
- 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
See the full eligibility 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 ICF
- Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC
- Documented activating 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-CNS lesion according to RECIST 1.1.
- Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the SmPC/Product Information
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Further inclusion criteria apply.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Korea, Democratic People's Republic of
- China
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Korea, Democratic People's Republic of; China; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.