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)
π©Ί 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: To join this study, participants generally need to meet the listed inclusion criteria (40 items) and avoid the listed exclusions (11 items).
Location: University of Alabama at Birmingham β Birmingham, Alabama
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening
- Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local treatment.
- Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication
- Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial
- Previous treatment with zongertinib.
- Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment. Further exclusion criteria apply.
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (85 Sites)
- University of Alabama at Birmingham β Birmingham, Alabama
- Precision NextGen Oncology β Beverly Hills, California
- City of Hope-Duarte-56419 β Duarte, California
- City of Hope - Seacliff β Huntington Beach, California
- City of Hope-Irvine-69674 β Irvine, California
- Valkyrie Clinical Trials β Los Angeles, California
- University of California Irvine β Orange, California
- University of California Davis β Sacramento, California
- Georgetown University β Washington D.C., District of Columbia
- Holy Cross Hospital-Fort Lauderdale-57892 β Fort Lauderdale, Florida
- Winship Cancer Institute β Atlanta, Georgia
- Hawaii Cancer Care - Honolulu β Honolulu, Hawaii
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health β New York, New York
- Duke University Medical Center β Durham, North Carolina
- Cleveland Clinic β Cleveland, Ohio
- Sarah Cannon Research Institute-Nashville-48456 β Nashville, Tennessee
- Mary Crowley Cancer Research Center β Dallas, Texas
- The University of Texas MD Anderson Cancer Center β Houston, Texas
- Virginia Cancer Specialists, PC β Fairfax, Virginia
- Fred Hutchinson Cancer Research Center β Seattle, Washington
- Macquarie University β Macquarie Park, New South Wales
- Ordensklinikum Linz GmbH β Linz,
- Brussels - HOSP Jules Bordet β Anderlecht/Brussels-Capital,
- Beijing Cancer Hospital β Beijing,
- Jilin Province Cancer Hospital β Changchun,
π° 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 Β§ 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.