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Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
NCT04886804 · View on ClinicalTrials.gov ↗
Study Summary
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Conditions Studied
Interventions
- DRUG zongertinib
Study Locations (20)
California
- Precision NextGen Oncology — Beverly Hills
- City of Hope-Duarte-56419 — Duarte
- City of Hope - Seacliff — Huntington Beach
- City of Hope-Irvine-69674 — Irvine
- Valkyrie Clinical Trials — Los Angeles
- University of California Irvine — Orange
- University of California Davis — Sacramento
Texas
- Mary Crowley Cancer Research Center — Dallas
- The University of Texas MD Anderson Cancer Center — Houston
Alabama
- University of Alabama at Birmingham — Birmingham
District of Columbia
- Georgetown University — Washington D.C.
Florida
- Holy Cross Hospital-Fort Lauderdale-57892 — Fort Lauderdale
Georgia
- Winship Cancer Institute — Atlanta
Hawaii
- Hawaii Cancer Care - Honolulu — Honolulu
New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2021-07-02 |
| Est. Completion | 2028-08-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04886804
The ClinicalTrials.gov registry entry for NCT04886804 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 608 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention — of which zongertinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04886804 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Texas, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04886804 about?
NCT04886804 is a clinical study titled "Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)". The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. ...
What is the current status of trial NCT04886804?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 608 participants. The study started on 2021-07-02. Estimated completion is 2028-08-30.
What conditions does trial NCT04886804 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Neoplasm Metastasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04886804?
The interventions under investigation include: zongertinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04886804?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04886804 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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