Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-27 @ 6:15 PM
Study NCT ID:
NCT04068168
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Status:
COMPLETED
Status Verified Date:
2025-11
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:
Imfinzi PMS
Brief Summary:
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Detailed Description:
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
* Dose interruptions
* Duration of treatment
* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
* Progression free survival (PFS)
* Objective response rate (ORR)
* Duration of response (DoR)
Outcome Measure:
* Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE))
* Dose interruptions
* Duration of treatment
* Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea
Outcome Measure:
* Progression free survival (PFS)
* Objective response rate (ORR)
* Duration of response (DoR)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: