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NCT04886804 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Non-Small Cell Lung Cancer and Neoplasm Metastasis, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 1
- Development phase
- 608
- Enrollment target
- 20
- Study locations
NCT04886804: Active Phase 1 study of Non-Small Cell Lung Cancer and Neoplasm Metastasis, sponsored by Boehringer Ingelheim.
NCT04886804 is a Phase 1 study of Non-Small Cell Lung Cancer and Neoplasm Metastasis that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 608 participants, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04886804, a Phase 1 study of Non-Small Cell Lung Cancer and Neoplasm Metastasis, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 608 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
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 |
What the registry record for NCT04886804 still lists
NCT04886804 is an interventional study that assigns participants to a tested intervention. The registered 608 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.
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.
NCT04886804 names 20 study sites across 13 states, led by California, Texas, Alabama.
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.
What interventions are being tested in trial NCT04886804?
The interventions under investigation include: zongertinib (DRUG).
Who is sponsoring clinical trial NCT04886804?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04886804's enrollment target sits among peer trials
608 54th of 454 higher than 401 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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