Clinical trial NCT04068168: Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Official title: Open Label, Multicenter, Real World Practice of Durvalumab (Imfinzi PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Biliary Tract Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 712
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Imfinzi treatment according to the approved label

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)

Eligibility criteria: 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

Primary outcomes:
measure: Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)
timeFrame: for up to 1 year after the first dose of Imfinzi
measure: Dose interruptions
timeFrame: for up to 1 year after the first dose of Imfinzi
measure: Duration of treatment
timeFrame: for up to 1 year after the first dose of Imfinzi
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: for up to 1 year after the first dose of Imfinzi
measure: Objective response rate (ORR)
timeFrame: for up to 1 year after the first dose of Imfinzi
measure: Duration of response (DoR)
timeFrame: for up to 1 year after the first dose of Imfinzi
Other outcomes:
Locations:
city: Changwon-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Chuncheon-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Hwasun-gun
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Iksan-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Jeju-do
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Pohang-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Wonju-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Yangsan-si
country: Korea, Republic of
facility: Research Site
state: South Korea
city: Anyang-si
country: Korea, Republic of
facility: Research Site
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Changwon
country: Korea, Republic of
facility: Research Site
city: Cheonan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Goyang-si
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seongnam-Si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
city: Yongin-si
country: Korea, Republic of
facility: Research Site
Study officials:
References: