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

AstraZeneca

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02777567

D5160R00009

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Volunteers: No 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