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).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03918304

Acronym

KOREA-PLUS

Enrollment

923

Registered

2019-04-17

Start date

2019-06-11

Completion date

2024-10-27

Last updated

2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

1. History of hypersensitivity to the active substance or to any of the excipients of this drug 2. Pregnancy and/or breast feeding 3. Current participation in any interventional trial

Design outcomes

Primary

Measure	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

Measure	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

Countries

South Korea

Outcome results