A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
NCT ID: NCT05769764
Last Updated: 2023-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
225 participants
OBSERVATIONAL
2022-12-19
2023-04-06
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: NSCLC
Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4.
Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.
Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI
Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples.
Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.
Cohort 3: ALK+ NSCLC
Participants with ALK+ NSCLC with matched samples.
Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.
Cohort 4: NSCLC Harboring a KRAS p.G12C Mutation or EGFR Exon 20 Insertion
Participants with NSCLC harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation or EGFR exon 20 insertion.
Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.
Interventions
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Archival tissue specimen and immunohistochemistry staining
This is a non-interventional study and no intervention will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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Baptist Health South Florida - Miami Cancer Institute
Miami, Florida, United States
McLeod Health
Florence, South Carolina, United States
Countries
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Other Identifiers
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U31402-0003-NIS-MA
Identifier Type: -
Identifier Source: org_study_id
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