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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: NSCLC | Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4. |
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| 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. |
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| Cohort 3: ALK+ NSCLC | Participants with ALK+ NSCLC with matched samples. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Archival tissue specimen and immunohistochemistry staining | Other | This is a non-interventional study and no intervention will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Additional population-specific inclusion criteria:
For Cohort 1:
For Cohort 2:
For Cohort 3:
For Cohort 4:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Florida - Miami Cancer Institute | Miami | Florida | 33176 | United States | ||
| McLeod Health |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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.
| Florence |
| South Carolina |
| 29506 |
| United States |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |