Clinical trial NCT05769764: A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
Official title: HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
HER3 Expression Prevalence
Archival Tissue Samples
Real-World Data
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The EMR database provided by GRN, an oncology-focused, mission-driven hospital consortium comprised of 37 cancer centers, 85 hospitals and more than two million oncology patients across 13 USA states (New York, Massachusetts, Rhode Island, Maryland, Virginia, South Carolina, Florida, Indiana, Kentucky, Missouri, Arkansas, Kansas, Oklahoma), will be used as the data source for this study.

Brief 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 criteria: 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

Primary outcomes:
measure: HER3 Expression Prevalence Estimate for the NSCLC Population, Overall
timeFrame: 6 months
measure: HER3 Expression Prevalence Estimate for the NSCLC Population, by Subgroup
timeFrame: 6 months
measure: HER3 Expression Prevalence Estimate for the NSCLC Population Before and After Treatment, by Patient Subpopulation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida - Miami Cancer Institute
state: Florida
city: Florence
country: United States
facility: McLeod Health
state: South Carolina
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Leader
role: STUDY_DIRECTOR
References: