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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03995875
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2019-07-25
• Primary Completion: 2024-01-11
• Study Completion: 2024-01-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Wakayama, Japan