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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04068168

Acronym

Imfinzi PMS

Enrollment

712

Registered

2019-08-28

Start date

2020-01-30

Completion date

2024-12-27

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Biliary Tract Cancer

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)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)	for up to 1 year after the first dose of Imfinzi	safety outcome
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

Secondary

Measure	Time frame	Description
Progression free survival (PFS)	for up to 1 year after the first dose of Imfinzi	efficacy outcome
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

Countries

South Korea

Outcome results