Skip to main content
OpenTrials
Completed

NCT Number: NCT04068168

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer, Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Anyang-si, South Korea

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)

    Time frame: for up to 1 year after the first dose of Imfinzi

    safety outcome

  2. Dose interruptions

    Time frame: for up to 1 year after the first dose of Imfinzi

    Safety outcome

  3. Duration of treatment

    Time frame: for up to 1 year after the first dose of Imfinzi

    Safety outcome

Secondary outcomes

  1. Progression free survival (PFS)

    Time frame: for up to 1 year after the first dose of Imfinzi

    efficacy outcome

  2. Objective response rate (ORR)

    Time frame: for up to 1 year after the first dose of Imfinzi

    efficacy outcome

  3. Duration of response (DoR)

    Time frame: for up to 1 year after the first dose of Imfinzi

    efficacy outcome

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: Imfinzi PMS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.