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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (85 Sites)
Showing the first 25 of 85 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Precision NextGen Oncology — Beverly Hills, California
- City of Hope-Duarte-56419 — Duarte, California
- City of Hope - Seacliff — Huntington Beach, California
- City of Hope-Irvine-69674 — Irvine, California
- Valkyrie Clinical Trials — Los Angeles, California
- University of California Irvine — Orange, California
- University of California Davis — Sacramento, California
- Georgetown University — Washington D.C., District of Columbia
- Holy Cross Hospital-Fort Lauderdale-57892 — Fort Lauderdale, Florida
- Winship Cancer Institute — Atlanta, Georgia
- Hawaii Cancer Care - Honolulu — Honolulu, Hawaii
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Duke University Medical Center — Durham, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- Sarah Cannon Research Institute-Nashville-48456 — Nashville, Tennessee
- Mary Crowley Cancer Research Center — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- Virginia Cancer Specialists, PC — Fairfax, Virginia
- Fred Hutchinson Cancer Research Center — Seattle, Washington
- Macquarie University — Macquarie Park, New South Wales
- Ordensklinikum Linz GmbH — Linz,
- Brussels - HOSP Jules Bordet — Anderlecht/Brussels-Capital,
- Beijing Cancer Hospital — Beijing,
- Jilin Province Cancer Hospital — Changchun,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.