IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer
IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
1 other identifier
observational
248
1 country
18
Brief Summary
To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch
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 2021
Typical duration for all trials
18 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 19, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedStudy Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2023
CompletedJuly 24, 2024
July 1, 2024
2.3 years
April 19, 2021
July 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
16weeks
Eligibility Criteria
Patients with extensive stage small cell lung cancer
You may qualify if:
- Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.
You may not qualify if:
- Patients who have no treatment history with the product (i.e.,durvalumab)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Chiba, Japan
Research Site
Fukuoka, Japan
Research Site
Gunma, Japan
Research Site
Hokkaido, Japan
Research Site
Hyōgo, Japan
Research Site
Kanagawa, Japan
Research Site
Miyagi, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Numakunai, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Saitama, Japan
Research Site
Shizuoka, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Wakayama, 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
- Target Duration
- 16 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2021
First Posted
April 22, 2021
Study Start
April 22, 2021
Primary Completion
July 25, 2023
Study Completion
July 25, 2023
Last Updated
July 24, 2024
Record last verified: 2024-07
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.