Skip to main content
OpenTrials
Completed

NCT Number: NCT03995875

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Japan Lung Cancer Society

Registry information

Official study title

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

Acronym: AYAME

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2019
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.