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

Non-Small Cell Lung Cancer Clinical Trial

— KOREA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777567
• Other study ID #: D5160R00009
• Status: Completed
• Start date: September 29, 2016
• Est. completion date: March 19, 2020

Study information

• Verified date: September 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Korea, Republic of	Research Site	South Korea

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)	Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)	up to one year
Primary	Severity of (S)AEs	Severity of (S)AEs	up to one year
Secondary	ORR (Objective response rate), if available	ORR (Objective response rate), if available	up to one year
Secondary	PFS (Progression free survival), if available	PFS (Progression free survival), if available	up to one year

External Links

•   redacted synopsis