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

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT02777567
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-13
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2016-09-29
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇰🇷 South Korea, Korea, Republic of