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

Daiichi Sankyo

Status: Completed

Conditions: Non-small Cell Lung Cancer

Treatments: Other: Archival tissue specimen and immunohistochemistry staining

Study type: Observational

Funder types: Industry

Identifiers

NCT05769764

U31402-0003-NIS-MA

Details and patient eligibility

About

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.

Full 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

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

225 participants in 4 patient groups

Cohort 1: NSCLC

Description:

Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4.

Treatment:

Other: Archival tissue specimen and immunohistochemistry staining

Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI

Description:

Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples.

Treatment:

Other: Archival tissue specimen and immunohistochemistry staining

Cohort 3: ALK+ NSCLC

Description:

Participants with ALK+ NSCLC with matched samples.

Treatment:

Other: Archival tissue specimen and immunohistochemistry staining

Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion

Description:

Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion.

Treatment:

Other: Archival tissue specimen and immunohistochemistry staining