A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
1 other identifier
observational
225
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2022
CompletedFirst Submitted
Initial submission to the registry
March 3, 2023
CompletedFirst Posted
Study publicly available on registry
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2023
CompletedApril 10, 2023
April 1, 2023
4 months
March 3, 2023
April 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
The overall HER3 expression prevalence estimate will be reported.
6 months
HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup
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.
6 months
HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation
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).
6 months
Study Arms (4)
Cohort 1: NSCLC
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
Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples.
Cohort 3: ALK+ NSCLC
Participants with ALK+ NSCLC with matched samples.
Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion
Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion.
Interventions
This is a non-interventional study and no intervention will be administered.
Eligibility Criteria
The EMR database provided by GRN, an oncology-focused, mission-driven hospital consortium comprised of 37 cancer centers, 85 hospitals and more than two million oncology patients across 13 USA states (New York, Massachusetts, Rhode Island, Maryland, Virginia, South Carolina, Florida, Indiana, Kentucky, Missouri, Arkansas, Kansas, Oklahoma), will be used as the data source for this study.
You may qualify if:
- Age ≥18 years in US
- Histologically or cytologically documented advanced or metastatic NSCLC
- At least one sample available and evaluable for HER3 expression
- 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
- 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
- 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
- samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (2)
Baptist Health South Florida - Miami Cancer Institute
Miami, Florida, 33176, United States
McLeod Health
Florence, South Carolina, 29506, United States
Biospecimen
Archived tissue samples (sourced from biopsies and resections performed as part of routine care) will be procured from Guardian Research Network (GRN) sites for patients who fulfill the study eligibility criteria. These tissue samples will be shipped to a CLIA-certified lab for analysis. De-identified HER3 expression data resulting from testing will be combined with existing clinical data from GRN's electronic medical record (EMR) database.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Leader
Daiichi Sankyo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2023
First Posted
March 15, 2023
Study Start
December 19, 2022
Primary Completion
April 6, 2023
Study Completion
April 6, 2023
Last Updated
April 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share