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 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
529
Incidence of pneumonitis and AESI
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
Time frame: 3 years
To assess progression free survival (PFS) of durvalumab
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.
Time frame: PFS is assessed as PFS median for time of 3 years
To assess overall survaival (OS) of durvalumab
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.
Time frame: OS is assessed as median OS for time of 3 years
Incidence of pneumonitis and AESIs in patient subset populations
Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations
Time frame: 3 years
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Toyoake, Aichi-ken, 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, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kasama, Ibaraki, Japan
...and 33 more locations