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IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04854590
Collaborator
(none)
248
Enrollment
28
Locations
28.3
Anticipated Duration (Months)
8.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    248 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
    Actual Study Start Date :
    Apr 22, 2021
    Anticipated Primary Completion Date :
    Aug 31, 2023
    Anticipated Study Completion Date :
    Aug 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) [16weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.

    Exclusion Criteria:

    -Patients who have no treatment history with the product (i.e.,durvalumab)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aichi Japan
    2 Research Site Aomori Japan
    3 Research Site Chiba Japan
    4 Research Site Fukui Japan
    5 Research Site Fukuoka Japan
    6 Research Site Gifu Japan
    7 Research Site Gunma Japan
    8 Research Site Hokkaido Japan
    9 Research Site Hyogo Japan
    10 Research Site Iwate Japan
    11 Research Site Kagoshima Japan
    12 Research Site Kanagawa Japan
    13 Research Site Miyagi Japan
    14 Research Site Nagano Japan
    15 Research Site Nagasaki Japan
    16 Research Site Niigata Japan
    17 Research Site Oita Japan
    18 Research Site Okayama Japan
    19 Research Site Osaka Japan
    20 Research Site Saga Japan
    21 Research Site Saitama Japan
    22 Research Site Tochigi Japan
    23 Research Site Tokushima Japan
    24 Research Site Tokyo Japan
    25 Research Site Tottori Japan
    26 Research Site Toyama Japan
    27 Research Site Wakayama Japan
    28 Research Site Yamaguchi Japan

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, Astrazeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT04854590
    Other Study ID Numbers:
    • D419QC00006
    First Posted:
    Apr 22, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Small Cell Lung Carcinoma
    Carcinoma, Small Cell

    Study Results

    No Results Posted as of Aug 17, 2022