Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
- Registration Number
- NCT03219970
- Lead Sponsor
- AstraZeneca
- Brief Summary
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- 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
- Enrolment in studies that prohibit any participation in this non-interventional study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description EGFR T790M positive NSCLC patients Osimertinib Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
- Primary Outcome Measures
Name Time Method Association between T790M mutant status and overal survival Followed up to 2 years after last patient in 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
- Secondary Outcome Measures
Name Time Method T790M mutation testing sample Within 14 days after enrollment date To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
Overal survival (OS) Followed up to 2 years after last patient in To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Treatment pattern Followed up to 2 years after last patient in To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.
T790M mutation testing platform Within 14 days after enrollment date 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
RR Follow up within 6 months after last patient in To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.
TTD Followed up to 12 months after last patient in 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)
Adverse event of special interest Followed up to 12 months after last patient in To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.
EGFR testing mutation subtype Within 14 days after enrollment date To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy
Trial Locations
- Locations (4)
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