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

AstraZeneca

Status: Completed

Conditions: Lung Cancer, Biliary Tract Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04068168

D4194R00004

Details and patient eligibility

About

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.

Full 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)

Enrollment: 712 patients

Sex: All

Volunteers: No 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