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Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04795245
Collaborator
(none)
800
Enrollment
1
Location
19.1
Anticipated Duration (Months)
41.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).

The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
800 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma
Actual Study Start Date :
Aug 26, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
patients treated with afatinib

Drug: afatinib
afatinib
Other Names:
  • Giotrif®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time on Treatment (TOT) with afatinib in first-line TOT (TOT1) [up to 48 months]

      This will be assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause.

    Secondary Outcome Measures

    1. TOT from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause [up to 48 months]

    2. TOT from start of the second-line treatment until end of the second-line treatment or death by any case (TOT2) [up to 48 months]

    3. overall survival [at month 18 and at month 36]

    4. survival rate [at month 18 and at month 36]

    5. time to initial dose reduction of afatinib [up to 48 months]

    6. proportion of patients with dose modifications of afatinib [up to 48 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)

    • Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry

    • Patients 20 years of age or older at the time of consent

    • Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.

    Exclusion Criteria:

    • Any contraindication to afatinib as specified in the label of Giotrif®

    • Patients treated with afatinib within an interventional trial

    • Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nippon Boehringer Ingelheim Co., Ltd. Tokyo Japan 141-6017

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT04795245
    Other Study ID Numbers:
    • 1200-0322
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Adenocarcinoma of Lung
    Afatinib

    Study Results

    No Results Posted as of Aug 10, 2022