Study identifier:D5160R00020
ClinicalTrials.gov identifier:NCT03219970
EudraCT identifier:N/A
CTIS identifier:N/A
An observational, non-interventional, multi-center, chart review study conducted among patients enrolled in an AZD9291 early access program in Hong Kong, with locally advanced/metastatic EGFR T790M mutation-positive NSCLC and prior exposure to EGFR TKI therapy.
Non-small Cell Lung Cancer
N/A
No
Osimertinib
All
156
Observational
18 Years - 100 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: -
Verified 01 Sept 2021 by AstraZeneca
AstraZeneca
-
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician’s judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.
Location
Location
Hong Kong, China
Location
Hong Kong, China
Location
Hong Kong, China
Location
Hong Kong, China
Arms | Assigned Interventions |
---|---|
EGFR T790M positive NSCLC patients Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment. | - |
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