Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS
KOREA-PLUS
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).
1 other identifier
observational
923
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
June 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2024
CompletedOctober 23, 2025
October 1, 2025
5.4 years
April 15, 2019
October 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Eligibility Criteria
On active study drug treatment according to the approved label
You may qualify if:
- \. 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
Research Site
Busan, South Korea
Research Site
Chungcheongbuk-do, South Korea
Research Site
Daegu, South Korea
Research Site
Daejeon, South Korea
Research Site
Gangwon State, South Korea
Research Site
Gyeonggi-do, South Korea
Research Site
Incheon, South Korea
Research Site
Jeollabuk-do, South Korea
Research Site
Jeollanam-do, South Korea
Research Site
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 17, 2019
Study Start
June 11, 2019
Primary Completion
October 27, 2024
Study Completion
October 27, 2024
Last Updated
October 23, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/DisclosureYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.