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

Study Overview

• Status: Completed
• Conditions: Lung Cancer, Biliary Tract Cancer

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)

• Study Type: Observational
• Enrollment (Actual): 712

Contacts and Locations

Study Locations

• South Korea
  • South Korea
    • Anyang-si, South Korea, South Korea
      • Research Site
    • Bucheon-si, South Korea, South Korea
      • Research Site
    • Busan, South Korea, South Korea
      • Research Site
    • Changwon, South Korea, South Korea
      • Research Site
    • Changwon-si, South Korea, South Korea
      • Research Site
    • Cheonan, South Korea, South Korea
      • Research Site
    • Chuncheon, South Korea, South Korea
      • Research Site
    • Daegu, South Korea, South Korea
      • Research Site
    • Daejeon, South Korea, South Korea
      • Research Site
    • Goyang-si, South Korea, South Korea
      • Research Site
    • Gwangju, South Korea, South Korea
      • Research Site
    • Hwasun-gun, South Korea, South Korea
      • Research Site
    • Iksan-si, South Korea, South Korea
      • Research Site
    • Incheon, South Korea, South Korea
      • Research Site
    • Jeju-do, South Korea, South Korea
      • Research Site
    • Jeonju, South Korea, South Korea
      • Research Site
    • Pohang-si, South Korea, South Korea
      • Research Site
    • Seongnam-si, South Korea, South Korea
      • Research Site
    • Seoul, South Korea, South Korea
      • Research Site
    • Suwon, South Korea, South Korea
      • Research Site
    • Uijeongbu-si, South Korea, South Korea
      • Research Site
    • Wŏnju, South Korea, South Korea
      • Research Site
    • Yangsan, South Korea, South Korea
      • Research Site
    • Yongin-si, South Korea, South Korea
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Imfinzi treatment according to the approved label

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)	safety outcome	for up to 1 year after the first dose of Imfinzi
Dose interruptions	Safety outcome	for up to 1 year after the first dose of Imfinzi
Duration of treatment	Safety outcome	for up to 1 year after the first dose of Imfinzi

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	efficacy outcome	for up to 1 year after the first dose of Imfinzi
Objective response rate (ORR)	efficacy outcome	for up to 1 year after the first dose of Imfinzi
Duration of response (DoR)	efficacy outcome	for up to 1 year after the first dose of Imfinzi

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): December 27, 2024
• Study Completion (Actual): December 27, 2024

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Lung Diseases; Biliary Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Biliary Tract Neoplasms; Lung Neoplasms
• Other Study ID Numbers: D4194R00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.