Imfinzi/Imjudo NSCLC Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - CEI/SCEI
Specific Use-results Study of IMJUDO Intravenous Infusion 25mg / IMFINZI Intravenous Infusion 120mg,500mg All Patient Investigation in Patients With Unresectable Advanced or Recurrent Non-small Cell Lung Cancer
1 other identifier
observational
296
1 country
28
Brief Summary
To collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer who receive combination therapy of IMJUDO, IMFINZI and other platinum-based anti-cancer agents under actual use in the postmarketing setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
28 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
April 6, 2023
CompletedFirst Posted
Study publicly available on registry
April 24, 2023
CompletedStudy Start
First participant enrolled
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedApril 14, 2026
March 1, 2026
1.9 years
April 6, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of ADRs
52 weeks
Eligibility Criteria
Patients with unresectable advanced or recurrent NSCLC
You may qualify if:
- All patients who receive IMJUDO, IMFINZI and other platinum-based anti-cancer agents for their unresectable advanced or recurrent NSCLC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (28)
Research Site
Aichi, Japan
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyōgo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Kagawa, Japan
Research Site
Kanagawa, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nara, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Toshimitsu Tokimoto
AstraZeneca KK
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2023
First Posted
April 24, 2023
Study Start
June 2, 2023
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
April 14, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.