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New treatment option for Lung Cancer, Non-squamous, Non-small Cell
Official title 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
ClinicalTrials.gov ID: NCT07486817
What this study is testing
What is Zongertinib?
Zongertinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lung cancer, non-squamous, non-small cell.
Also referred to as Hernexeos®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 informed...
- 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
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...
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after...
- 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...
- 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 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
- 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 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 how well it works of...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- St Leonards, New South Wales, Australia
- Malvern, Victoria, Australia
- Murdoch, Western Australia, Australia
- Guangzhou, China
- Shanghai, China
- Lyon, France
- Paris, France
- Cologne, Germany
- Heidelberg, Germany
- Osaka, Sakai, Japan
- Tokyo, Chuo-ku, Japan
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- Seville, Spain
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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Leonards, New South Wales, Australia; Malvern, Victoria, Australia; Murdoch, Western Australia, Australia; Guangzhou, China; Shanghai, China; Lyon, France and 9 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.