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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769764
• Other study ID #: U31402-0003-NIS-MA
• Status: Completed
• Start date: December 19, 2022
• Est. completion date: April 6, 2023

Study information

• Verified date: April 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.

Locations

Country	Name	City	State
United States	McLeod Health	Florence	South Carolina
United States	Baptist Health South Florida - Miami Cancer Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HER3 Expression Prevalence Estimate for the NSCLC Population, Overall	The overall HER3 expression prevalence estimate will be reported.	6 months
Primary	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
Primary	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