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CompletedNot applicableNCT05769764
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedArchival tissue specimen and immunohistochemistry staining

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 10, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Daiichi Sankyo

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Daiichi Sankyo
Interventions being studied
Other: Archival tissue specimen and immunohistochemistry staining
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Baptist Health South Florida - Miami Cancer InstituteMiami, Florida
  • McLeod HealthFlorence, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 10, 2023. Always confirm current availability with the study team.

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