Study identifier:D4194R00004
ClinicalTrials.gov identifier:NCT04068168
EudraCT identifier:N/A
CTIS identifier:N/A
Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Lung Cancer, Biliary Tract cancer
N/A
No
-
All
712
Observational
n/a - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
-
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.
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)
Location
Location
Seoul, South Korea, Republic of Korea
Location
Suwon-si, South Korea, Republic of Korea
Location
Hwasun-gun, South Korea, Republic of Korea
Location
Jeonju-si, South Korea, Republic of Korea
Location
Incheon, South Korea, Republic of Korea
Location
Iksan-si, South Korea, Republic of Korea
Location
Busan, South Korea, Republic of Korea
Location
Changwon, South Korea, Republic of Korea
Arms | Assigned Interventions |
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