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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Archival tissue specimen and immunohistochemistry staining

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

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Health South Florida - Miami Cancer Institute
  • South Carolina
    • Florence, South Carolina, United States, 29506
      • McLeod Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1: NSCLC; 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; This is a non-interventional study and no intervention will be administered.
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.	Other: Archival tissue specimen and immunohistochemistry staining; This is a non-interventional study and no intervention will be administered.
Cohort 3: ALK+ NSCLC; Participants with ALK+ NSCLC with matched samples.	Other: Archival tissue specimen and immunohistochemistry staining; This is a non-interventional study and no intervention will be administered.
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.	Other: Archival tissue specimen and immunohistochemistry staining; This is a non-interventional study and no intervention will be administered.

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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.
• Investigators: Study Director: Clinical Leader, Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2022
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer; Real-World Data; HER3 Expression Prevalence; Archival Tissue Samples
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: U31402-0003-NIS-MA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No