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OpenTrials
Completed

NCT Number: NCT02777567

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

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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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

    Time frame: up to one year

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

  2. Severity of (S)AEs

    Time frame: up to one year

    Severity of (S)AEs

Secondary outcomes

  1. ORR (Objective response rate), if available

    Time frame: up to one year

    ORR (Objective response rate), if available

  2. PFS (Progression free survival), if available

    Time frame: up to one year

    PFS (Progression free survival), if available

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: KOREA

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 19, 2016
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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