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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-29

Study Completion Date

2020-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No