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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
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

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
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Chungcheongbuk-doSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
Gangwon StateSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
Gyeonggi-doSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
Jeollabuk-doSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
Jeollanam-doSouth KoreaUnknown status
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Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.