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.
Study Type
OBSERVATIONAL
Enrollment
156
80mg oral daily
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Prince of wales hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Association between T790M mutant status and overal survival
To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Time frame: Followed up to 2 years after last patient in
Overal survival (OS)
To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Time frame: Followed up to 2 years after last patient in
RR
To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.
Time frame: Follow up within 6 months after last patient in
TTD
To estimate time to treatment discontinuation (TTD) of osimertinib for the overall study population, and for subjects with different EGFR mutation status (T790M/Exon 19 del; T790M/L858R)
Time frame: Followed up to 12 months after last patient in
Adverse event of special interest
To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.
Time frame: Followed up to 12 months after last patient in
T790M mutation testing sample
To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
Time frame: Within 14 days after enrollment date
T790M mutation testing platform
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To describe the characteristics of the methods used for T790M mutation testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
Time frame: Within 14 days after enrollment date
EGFR testing mutation subtype
To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy
Time frame: Within 14 days after enrollment date
Treatment pattern
To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.
Time frame: Followed up to 2 years after last patient in