Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorBayer
About this trial
The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.
Eligibility criteria
Qualifiers
Signed and dated written informed consent
Age ≥18 years
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
Documented disease progression after treatment with at least one prior systemic therapy for advanced disease
Disqualifiers
Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy
Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2
Symptomatic or unstable brain metastases
Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP
Trial design
Treatments tested in this trial
- Sevabertinib
Treatment groups
No treatment groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov