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Clinical Trials in China / NCT07486817
Recruiting Phase 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

NCT07486817 · tracked via the Priya Life Science China tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2026-06-04
Last updated
2026-09-01

Condition(s) studied

Lung Cancer, Non-squamous, Non-small Cell

Investigational drug(s) / intervention(s)

Zongertinib →Cisplatin →Carboplatin →Pemetrexed →Pembrolizumab →

Zongertinib: Zongertinib

Cisplatin: Cisplatin

Carboplatin: Carboplatin

Pemetrexed: Pemetrexed

Pembrolizumab: Pembrolizumab

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Royal North Shore Hospital St Leonards New South Wales Not Yet Recruiting
Cabrini Health Malvern Victoria Recruiting
Fiona Stanley Hospital Murdoch Western Australia Recruiting
Guangdong Provincial People's Hospital Guangzhou China Recruiting
Shanghai Geriatric Medical Center Shanghai China Recruiting
CTR Leon Berard Lyon France Recruiting
INS Curie Paris France Recruiting
Universitätsklinikum Köln (AöR) Cologne Germany Recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg Germany Recruiting
Kindai University Hospital Osaka, Sakai Japan Recruiting
National Cancer Center Hospital Tokyo, Chuo-ku Japan Recruiting
Severance Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Virgen del Rocío Seville Spain Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07486817 on ClinicalTrials.gov ↗ ← All trials in China