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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05769764
Other study ID # U31402-0003-NIS-MA
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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