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A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

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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

NCT05769764•Daiichi Sankyo

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

Eligibility

Age

18 - No limit years

Sex

ALL

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
•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
+4 more criteria

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

Locations (2)

Baptist Health South Florida - Miami Cancer Institute

Miami, Florida, United States

McLeod Health

Florence, South Carolina, United States

Key Dates

Start Date

December 19, 2022

Primary Completion Date

April 6, 2023

Completion Date

April 6, 2023

Last Updated

April 10, 2023

Enrollment

225

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

Archival tissue specimen and immunohistochemistry staining

OTHER

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)