NCT07486817RecruitingPhase 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
Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 12 Mar 2026
- Start date
- 4 Jun 2026
- Primary completion date
- 12 Aug 2027
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Lung cancer
- NCT number
- NCT07486817
- EU CT number
- 2025-523567-38-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 4 Jun 2026 to the primary completion date, 12 Aug 2027
- 17 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tumors with targetable alterations with approved available therapy
- 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.
Other illness
- Presence or history of leptomeningeal disease
Who the study is looking for
- 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 inclusion criteria apply.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cabrini Health Coordinator of this site? Confirm its status | Malvern | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Not yet recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Shanghai Geriatric Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Universitaetsklinikum Koeln AöR Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka, Sakai | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Tokyo, Chuo-ku | Japan | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.