Imjudo & Imfinzi PMS
Imjudo & Imfinzi Post-Marketing Surveillance
1 other identifier
observational
246
1 country
6
Brief Summary
Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
April 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
November 21, 2025
November 1, 2025
3.9 years
August 6, 2024
November 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
For Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.
Secondary Outcomes (1)
Objective Response Rate(ORR)
For 1 year from the first dose of the treatment
Other Outcomes (1)
Disease Control Rate (DCR)
For 1 year from the first dose of the treatment
Eligibility Criteria
Patients who initiate treatment with study drugs after the contract date for the first time.
You may qualify if:
- Patients eligible for the study drugs according to the approved label in Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
You may not qualify if:
- Other off-label indications according to the approved label in South Korea
- Current participation in any interventional trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (6)
Research Site
Busan, South Korea
Research Site
Goyang, South Korea
Research Site
Seongnam, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 9, 2024
Study Start
April 14, 2025
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
February 28, 2029
Last Updated
November 21, 2025
Record last verified: 2025-11