Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
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About
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Full description
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.
Enrollment
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Inclusion criteria
- Patients enrolled in AZD9291 Named Patient Program in Hong Kong
- Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
- Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
- Provision of written informed consent (for patients alive at the time of study enrolment)
- Documented patients with trackable medical records
Exclusion criteria
- Enrolment in studies that prohibit any participation in this non-interventional study
Trial design
156 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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