A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.
Checked against the public recordLast updated Apr 10, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Daiichi Sankyo
- Interventions being studied
- Other: Archival tissue specimen and immunohistochemistry staining
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Age ≥18 years in US * Histologically or cytologically documented advanced or metastatic NSCLC * At least one sample available and evaluable for HER3 expression Additional population-specific inclusion criteria: For Cohort 1: * Tissue sample collected on or after January 1, 2013 For Cohort 2: * EGFRm NSCLC previously treated with a 3rd generation EGFR TKI * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a 3rd generation TKI (defined as Osimertinib, Aumolertinib \[formerly Almonertinib\]) For Cohort 3: * ALK+ NSCLC * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a TKI For Cohort 4: * NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment Exclusion Criteria: * Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination) * Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor * Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Baptist Health South Florida - Miami Cancer InstituteMiami, Florida
- McLeod HealthFlorence, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 10, 2023. Always confirm current availability with the study team.