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)
Public ClinicalTrials.gov record NCT04886804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Beamion LUNG-1: An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of Zongertinib (BI 1810631) as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04886804
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 554 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2021 (Actual)
- Primary completion
- Dec 30, 2026 (Estimated)
- Completion
- Aug 30, 2028 (Estimated)
- Last update posted
- Oct 5, 2026
2021 – 2028
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Precision NextGen Oncology | Beverly Hills | California | 90212 | — |
| City of Hope-Duarte-56419 | Duarte | California | 91010 | — |
| City of Hope - Seacliff | Huntington Beach | California | 92648 | — |
| City of Hope-Irvine-69674 | Irvine | California | 92618 | — |
| Valkyrie Clinical Trials | Los Angeles | California | 90067 | — |
| University of California Irvine | Orange | California | 92868 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Holy Cross Hospital-Fort Lauderdale-57892 | Fort Lauderdale | Florida | 33308 | — |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Hawaii Cancer Care - Honolulu | Honolulu | Hawaii | 96813 | — |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | 10016 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Sarah Cannon Research Institute-Nashville-48456 | Nashville | Tennessee | 37203 | — |
| Mary Crowley Cancer Research Center | Dallas | Texas | 75230 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04886804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04886804 live on ClinicalTrials.gov.