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

December 3, 2024 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

529

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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
        • Research Site
    • Aichi
      • Nagoya, Aichi, Japan
        • Research Site
      • Toyoake, Aichi, Japan
        • Research Site
    • Ehime
      • Matsuyama, Ehime, Japan
        • Research Site
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Research Site
    • Gunma
      • Maebashi, Gunma, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Akashi, Hyogo, Japan
        • Research Site
      • Kobe, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Kasama, Ibaraki, Japan
        • Research Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Research Site
    • Iwate
      • Morioka, Iwate, Japan
        • Research Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Mie
      • Matsubara, Mie, Japan
        • Research Site
    • Miyagi
      • Natori, Miyagi, Japan
        • Research Site
      • Sendai, Miyagi, Japan
        • Research Site
    • Okinawa
      • Nishihara, Okinawa, Japan
        • Research Site
    • Osaka
      • Hirakata, Osaka, Japan
        • Research Site
      • Osakasayama, Osaka, Japan
        • Research Site
      • Sakai, Osaka, Japan
        • Research Site
    • Saitama
      • Hidaka, Saitama, Japan
        • Research Site
    • Shimane
      • Izumo, Shimane, Japan
        • Research Site
    • Shizuoka
      • Mishima, Shizuoka, Japan
        • Research Site
    • Tochigi
      • Mibu, Tochigi, Japan
        • Research Site
      • Shimotsuke, Tochigi, Japan
        • Research Site
    • Tokyo
      • 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
    • Yamaguchi
      • Iwakuni, Yamaguchi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years
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.
PFS is assessed as PFS median for time of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
OS is assessed as median OS for time of 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Japan Lung Cancer Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

January 11, 2024

Study Completion (Actual)

January 11, 2024

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4194R00013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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