NCT04886804

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)

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Neoplasm Metastasis
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	zongertinib	zongertinib

Timeline

• Start date: 2021-07-02
• Primary completion: 2026-12-30
• Completion: 2028-08-30
• First posted: 2021-05-14
• Last updated: 2026-03-13

Locations

85 sites across 18 countries: United States, Australia, Austria, Belgium, China, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study