Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS

Study Overview
=================
Brief Summary
-----------------
This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter the study drug) in a real world setting according to the approved label in Korea.

Detailed Description
-----------------
Primary objective: To assess safety of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea.

Official Title
-----------------
Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso; KOREA PLUS Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS).

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Eligible for, or on active study drug treatment according to the approved prescribing information; The first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have been previously treated with EGFR TKI therapy The adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: History of hypersensitivity to the active substance or to any of the excipients of this drug Pregnancy and/or breast feeding Current participation in any interventional trial
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) |  | For about 1 year since the first dose of the study drug | 
| Severity of (S)AEs according to CTCAE |  | For about 1 year since the first dose of the study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR (Objective response rate), if available |  | For about 1 year since the first dose of the study drug | 
| PFS (Progression free survival) , if available |  | For about 1 year since the first dose of the study drug | 
| DFS (Disease free survival), if available |  | For about 1 year since the first dose of the study drug |