Clincosm LogoSign in Get a demo

An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT03457220
Collaborator
(none)
423
Enrollment
7
Locations
18.3
Actual Duration (Months)
60.4
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    423 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment
    Actual Study Start Date :
    Jun 21, 2018
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months]

      PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression

    Secondary Outcome Measures

    1. Overall survival (OS) [Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months]

      OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause

    Other Outcome Measures

    1. Response Rate (RR) [Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months]

      RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment

    2. Disease Control Rate (DCR) [Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months]

      DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment.

    3. Time to treatment discontinuation (TTD) [Time from patient first dose to data cut off (up to 32 months)]

      TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason

    Eligibility Criteria

    Criteria

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

    • At least 20 years of age

    • Patients who were in the AZD9291 Early Access Program

    • Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents

    • Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018

    • Patients agree to provide the written informed consent or the informed consent is waived by IRB.

    Exclusion Criteria:

    • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Kaohsiung Taiwan 807
    2 Research Site Kaohsiung Taiwan 83301
    3 Research Site Taichung Taiwan 40705
    4 Research Site Tainan City Taiwan 70403
    5 Research Site Tainan City Taiwan 73657
    6 Research Site Taipei Taiwan 10002
    7 Research Site Taipei Taiwan 112

    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:
    NCT03457220
    Other Study ID Numbers:
    • D5160R00021
    First Posted:
    Mar 7, 2018
    Last Update Posted:
    Dec 21, 2020
    Last Verified:
    Dec 1, 2020
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Dec 21, 2020