A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Other: Archival tissue specimen and immunohistochemistry staining
- Registration Number
- NCT05769764
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
The purpose of this study is to use archival tissue samples and RW data to generate HER3 expression prevalence data within the NSCLC population and by patient characteristics (e.g., ethnicity, histology, smoking status, age, prior treatment, etc.).
The primary objective of the study will analyze and assess archival tissue specimens and associated RW data to:
* Increase the understanding of HER3 expression in NSCLC among HCPs and the medical community
* Generate evidence to support future clinical strategies in this area
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion Archival tissue specimen and immunohistochemistry staining Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion. Cohort 1: NSCLC Archival tissue specimen and immunohistochemistry staining Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4. Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI Archival tissue specimen and immunohistochemistry staining Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples. Cohort 3: ALK+ NSCLC Archival tissue specimen and immunohistochemistry staining Participants with ALK+ NSCLC with matched samples.
- Primary Outcome Measures
Name Time Method HER3 Expression Prevalence Estimate for the NSCLC Population, Overall 6 months The overall HER3 expression prevalence estimate will be reported.
HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup 6 months HER3 expression prevalence estimate will be reported by subgroup, including age, gender, smoking status, epidermal growth factor receptor (EGFR) status, AGA status, ethnicity, and location of biopsy.
HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation 6 months HER3 expression prevalence estimate before and after treatment will be reported by patient subpopulation (EGFRm NSCLC previously treated with a 3rd generation EGFR TKI, ALK+ NSCLC, NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Baptist Health South Florida - Miami Cancer Institute
🇺🇸Miami, Florida, United States
McLeod Health
🇺🇸Florence, South Carolina, United States
Baptist Health South Florida - Miami Cancer Institute🇺🇸Miami, Florida, United States