Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Osimertinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGFR T790M positive NSCLC patients<br>Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment. | Drug: Osimertinib<br>* 80mg oral daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Followed up to 2 years after last patient in | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overal survival (OS) | To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib | 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. | 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) | 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. | 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 | Within 14 days after enrollment date | 
| T790M mutation testing platform | 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 | 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 | Within 14 days after enrollment date | 
| Treatment pattern | To describe treatment regimens received by study subjects before and after the start of osimertinib therapy. | Followed up to 2 years after last patient in |