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出境医 / 临床实验 / Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC (AYAME)

Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC (AYAME)

Study Description
Brief Summary:
This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.

Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:

Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.

Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 527 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Incidence of pneumonitis and AESI [ Time Frame: 3 years ]

    Pneumonitis and AESIs will be summarized at least following categories

    • Pneumonitis within three years from the start of durvalmab treatment
    • Pneumonitis and AESIs during treatment period of durvalmab
    • Pneumonitis and AESIs after durvalmab treatment

  2. To assess progression free survival (PFS) of durvalumab [ Time Frame: PFS is assessed as PFS median for time of 3 years ]
    PFS is defined as the time from the start of durvalumab treatment to first progression disease (PD) or death, whichever is earlier. In case the patients without progression or death, patients will be censored at the last follow-up date or the first date of the 1st subsequent treatment, whichever is earlier.


Secondary Outcome Measures :
  1. To assess overall survaival (OS) of durvalumab [ Time Frame: OS is assessed as median OS for time of 3 years ]
    OS is defined as the time from the date of start of the durvalumab treatment until death due to any causes. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

  2. Incidence of pneumonitis and AESIs in patient subset populations [ Time Frame: 3 years ]
    Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Total 500 patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy will be enrolled. The patients should be registered consecutively in each site.
Criteria

Inclusion Criteria:

  • Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
  • Patients who provided written informed consent.

Exclusion Criteria:

  • Patients who would join Post Marketing Surveyllance for durvalumab.
  • Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment
  • Age < 20
Contacts and Locations

Locations
Layout table for location information
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Toyoake, Aichi, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Kurume, Fukuoka, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kasama, Ibaraki, Japan
Research Site
Kanazawa, Ishikawa, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Matsubara, Mie, Japan
Research Site
Natori, Miyagi, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Nishihara, Okinawa, Japan
Research Site
Hirakata, Osaka, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Hidaka, Saitama, Japan
Research Site
Izumo, Shimane, Japan
Research Site
Mishima, Shizuoka, Japan
Research Site
Mibu, Tochigi, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Iwakuni, Yamaguchi, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Tokushima, Japan
Research Site
Wakayama, Japan
Sponsors and Collaborators
AstraZeneca
Japan Lung Cancer Society
Tracking Information
First Submitted Date June 6, 2019
First Posted Date June 24, 2019
Last Update Posted Date April 12, 2021
Actual Study Start Date July 25, 2019
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2019)
  • Incidence of pneumonitis and AESI [ Time Frame: 3 years ]
    Pneumonitis and AESIs will be summarized at least following categories
    • Pneumonitis within three years from the start of durvalmab treatment
    • Pneumonitis and AESIs during treatment period of durvalmab
    • Pneumonitis and AESIs after durvalmab treatment
  • To assess progression free survival (PFS) of durvalumab [ Time Frame: PFS is assessed as PFS median for time of 3 years ]
    PFS is defined as the time from the start of durvalumab treatment to first progression disease (PD) or death, whichever is earlier. In case the patients without progression or death, patients will be censored at the last follow-up date or the first date of the 1st subsequent treatment, whichever is earlier.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2019)
  • To assess overall survaival (OS) of durvalumab [ Time Frame: OS is assessed as median OS for time of 3 years ]
    OS is defined as the time from the date of start of the durvalumab treatment until death due to any causes. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
  • Incidence of pneumonitis and AESIs in patient subset populations [ Time Frame: 3 years ]
    Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC
Official Title Real World Evidence of Long-term Safety and Efficacy in Patients Treated With Durvalumab After Concurrent Chemoradiation for Unresectable Stage III NSCLC.
Brief Summary This observational study is designed to assess the long term safety of the durvalumab treatment period including subsequent treatment period and demonstrate the efficacy of patients treated with durvalumab following chemoradiation therapy in the real world.
Detailed Description

Study design: Prospective multi-center non-interventional cohort study Data Source(s): Medical records of patients who are treated with durvalumab following chemoradiation therapy Study Population: Patients prescribed and treated with durvalumab for unresectable stage III non-small cell lung cancer (NSCLC) at first time following chemoradiation therapy and who provide written informed consent.

Exposure(s): durvalumab Outcome(s): Summary of pneumonitis and adverse event special interest (AESI), progression free survaival (PFS), overall survaival (OS), Reasons of discontinuation of durvalumab treatment, Details of subsequent treatments after durvalumab Sample Size Estimations: 500 patients Statistical Analysis: Only descriptive analysis and no formal test

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Total 500 patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy will be enrolled. The patients should be registered consecutively in each site.
Condition Carcinoma, Non-Small-Cell Lung
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 13, 2021)
527
Original Estimated Enrollment
 (submitted: June 21, 2019)
500
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients who receive durvalumab for unresectable stage III NSCLC at first time following chemoradiation therapy.
  • Patients who provided written informed consent.

Exclusion Criteria:

  • Patients who would join Post Marketing Surveyllance for durvalumab.
  • Patients who would join any interventional clinical studies using unapproved drugs or off-label use of drugs from first diagnosis to the end of the durvalumab treatment
  • Age < 20
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03995875
Other Study ID Numbers D4194R00013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Japan Lung Cancer Society
Investigators Not Provided
PRS Account AstraZeneca
Verification Date April 2021

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