Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Conditions:

Lung Cancer, Biliary Tract Cancer

Eligibility:

All Genders

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), ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

January 30 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 27 2024

Estimated Enrollment :

712 Patients enrolled

Trial Details

Trial ID

NCT04068168

Start Date

January 30 2020

End Date

December 27 2024

Last Update

November 17 2025

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Research Site

Anyang-si, South Korea, South Korea

2

Research Site

Bucheon-si, South Korea, South Korea

3

Research Site

Busan, South Korea, South Korea

4

Research Site

Changwon, South Korea, South Korea