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).

AstraZeneca1 site in 1 country923 target enrollmentJune 11, 2019

ConditionsCarcinoma, Non-Small-Cell Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: AstraZeneca
Enrollment: 923
Locations: 1
Primary Endpoint: Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 11, 2019

End Date

October 27, 2024

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility 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
•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

Outcomes

Primary Outcomes

Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

Time Frame: For about 1 year since the first dose of the study drug

Severity of (S)AEs according to CTCAE

Time Frame: For about 1 year since the first dose of the study drug

Secondary Outcomes

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)