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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02777567
Collaborator
(none)
315
Enrollment
1
Location
41.6
Actual Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    315 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Sep 29, 2016
    Actual Primary Completion Date :
    Mar 19, 2020
    Actual Study Completion Date :
    Mar 19, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. Severity of (S)AEs [up to one year]

      Severity of (S)AEs

    Secondary Outcome Measures

    1. ORR (Objective response rate), if available [up to one year]

      ORR (Objective response rate), if available

    2. PFS (Progression free survival), if available [up to one year]

      PFS (Progression free survival), if available

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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
      1. 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
      1. Pregnancy and/or breast feeding
      1. Current participation in any interventional trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site South Korea Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02777567
    Other Study ID Numbers:
    • D5160R00009
    First Posted:
    May 19, 2016
    Last Update Posted:
    Sep 10, 2020
    Last Verified:
    Sep 1, 2020
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Sep 10, 2020