A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer

Study Overview
=================
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

Official Title
-----------------
HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Archival tissue specimen and immunohistochemistry staining


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: NSCLC<br>Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4. | Other: Archival tissue specimen and immunohistochemistry staining<br>* This is a non-interventional study and no intervention will be administered.<br>|
| Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI<br>Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples. | Other: Archival tissue specimen and immunohistochemistry staining<br>* This is a non-interventional study and no intervention will be administered.<br>|
| Cohort 3: ALK+ NSCLC<br>Participants with ALK+ NSCLC with matched samples. | Other: Archival tissue specimen and immunohistochemistry staining<br>* This is a non-interventional study and no intervention will be administered.<br>|
| Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion<br>Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion. | Other: Archival tissue specimen and immunohistochemistry staining<br>* This is a non-interventional study and no intervention will be administered.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-small Cell Lung Cancer, HER3 Expression Prevalence, Archival Tissue Samples, Real-World Data