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KOREA-PLUS: Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS

Sponsor
AstraZeneca (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03918304
Collaborator
(none)
2,000
Enrollment
11
Locations
60
Anticipated Duration (Months)
181.8
Patients Per Site
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. 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 according to the approved label in Korea.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    • Primary objective: To assess safety of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea

    • Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso; KOREA PLUS Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS).
    Actual Study Start Date :
    Jun 30, 2019
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI) [For about 1 year since the first dose of the study drug]

    2. Severity of (S)AEs according to CTCAE [For about 1 year since the first dose of the study drug]

    Secondary Outcome Measures

    1. ORR (Objective response rate), if available [For about 1 year since the first dose of the study drug]

    2. PFS (Progression free survival) , if available [For about 1 year since the first dose of the study drug]

    3. DFS (Disease free survival), if available [For about 1 year since the first dose of the study drug]

    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 prescribing information;

    • The first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations

    • Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have been previously treated with EGFR TKI therapy

    • The adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

    • Exclusion Criteria:

    1. History of hypersensitivity to the active substance or to any of the excipients of this drug

    2. Pregnancy and/or breast feeding

    3. Current participation in any interventional trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Busan Korea, Republic of
    2 Research Site Busan Korea, Republic of
    3 Research Site Daegu Korea, Republic of
    4 Research Site Gyeonggi-do Korea, Republic of
    5 Research Site Gyeonggi-do Korea, Republic of
    6 Research Site Gyeonggi-do Korea, Republic of
    7 Research Site Incheon Korea, Republic of
    8 Research Site Jeollabuk-do Korea, Republic of
    9 Research Site Jeollanam-do Korea, Republic of
    10 Research Site Seoul Korea, Republic of
    11 Research Site Seoul Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT03918304
    Other Study ID Numbers:
    • D5161R00005
    First Posted:
    Apr 17, 2019
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 19, 2022