NCT03918304Completed
Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - 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).
Source: ClinicalTrials.gov · Last updated 23 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 923 (actual)
- First submitted
- 15 Apr 2019
- Start date
- 11 Jun 2019
- Primary completion date
- 27 Oct 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT03918304
What you commit to
- Study type: Observational
- Participants enrolled: 923
- From 11 Jun 2019 to the primary completion date, 27 Oct 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Chungcheongbuk-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Gangwon State | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Jeollabuk-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.