Non-small Cell Lung Cancer Clinical Trial
Official title:
HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
Verified date | April 2023 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | McLeod Health | Florence | South Carolina |
United States | Baptist Health South Florida - Miami Cancer Institute | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo, Inc. |
United States,
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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