Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
NSCLC, stageIII, Durvalumab, Japanese, Real world
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
Interventions
None listed
Sponsors
Japan Lung Cancer Society
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pneumonitis and AESI | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| To assess overall survaival (OS) of durvalumab | 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 | 3 years | Summary of pneumonitis and AESIs in each durvalumab treatment status in patient subset populations |
Countries
Japan
Outcome results
None listed