Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-01 @ 1:44 PM
Study NCT ID:
NCT03918304
Status:
COMPLETED
Last Update Posted:
2025-10-23
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS
Sponsor:
AstraZeneca
Organization:
Study Overview
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).
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KOREA-PLUS
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.
* Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: