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. 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 t

Trial Details

NCT ID
NCT04886804
Phase
PHASE1
Sponsor
Boehringer Ingelheim
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • zongertinib
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Duarte, California, United States|34.13945,-117.97729
  • Huntington Beach, California, United States|33.6603,-117.99923
  • Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

  • Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must show p…
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6, 7 and 9) .
  • Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2…
  • Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).

For full eligibility, visit ClinicalTrials.gov.

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