Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)

Completed

• Conditions: Lung Cancer, Biliary Tract Cancer

• Registration Number: NCT04068168
• Lead Sponsor: AstraZeneca

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)

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Study Start: 2020-01-30
• Primary Completion: 2024-12-27
• Study Completion: 2024-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

Inclusion Criteria

• Eligible for Imfinzi treatment according to the approved label
• Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria

• Current participation in any interventional trial
• Other off-label indications according to the approved label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose interruptions	for up to 1 year after the first dose of Imfinzi	Safety outcome
Duration of treatment	for up to 1 year after the first dose of Imfinzi	Safety outcome
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)	for up to 1 year after the first dose of Imfinzi	safety outcome

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	for up to 1 year after the first dose of Imfinzi	efficacy outcome
Duration of response (DoR)	for up to 1 year after the first dose of Imfinzi	efficacy outcome
Progression free survival (PFS)	for up to 1 year after the first dose of Imfinzi	efficacy outcome

Trial Locations

Locations (1)

Research Site; 🇰🇷 Yongin-si, Korea, Republic of