Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04529564
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2020-07-01
Brief Title:
Real-world Data on Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area PACIFIC AA
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy in Asia Area
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy in Asia Area
Detailed Description:
Study Design The study is an observational review of medical records of patients diagnosed with unresectable stage III NSCLC in Taiwan participating in an early access program EAP Physicians having treated patients in the EAP will be asked to recruit these patients to have their data abstracted from their medical records Data will only be collected from routine clinical care
Data Sources Centre staff will extract de-identified data from patients medical charts All collected data will be retrospective at time of extractions
Study Population Patients diagnosed with an unresectable stage III NSCLC having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population
Exposures Clinical characteristics details of treatments previous therapies subsequent therapies durvalumab exposure and serious AESIs Primary Outcomes PFS and OS Sample Size Estimations A target of 140 patients is estimated in the study
Data Sources Centre staff will extract de-identified data from patients medical charts All collected data will be retrospective at time of extractions
Study Population Patients diagnosed with an unresectable stage III NSCLC having not progressed after a CRT and who have received at least one dose of durvalumab following the CRT within the EAP will be the target population
Exposures Clinical characteristics details of treatments previous therapies subsequent therapies durvalumab exposure and serious AESIs Primary Outcomes PFS and OS Sample Size Estimations A target of 140 patients is estimated in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None