KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso for Patients With Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation-Positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or After EGFR Tyrosine Kinase Receptor (TKI) Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02777567

Acronym

KOREA

Enrollment

315

Registered

2016-05-19

Start date

2016-09-29

Completion date

2020-03-19

Last updated

2020-09-10

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

Conditions

Non-Small Cell Lung Cancer

Brief summary

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 in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* 1\. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy * 2\. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion criteria

* 1\. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug * 2\. Pregnancy and/or breast feeding * 3\. Current participation in any interventional trial

Design outcomes

Primary

Measure	Time frame	Description
Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)	up to one year	Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Severity of (S)AEs	up to one year	Severity of (S)AEs

Secondary

Measure	Time frame	Description
ORR (Objective response rate), if available	up to one year	ORR (Objective response rate), if available
PFS (Progression free survival), if available	up to one year	PFS (Progression free survival), if available

Countries

South Korea

Outcome results