- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04854590
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chiba, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Gunma, Japan
- Research Site
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Hokkaido, Japan
- Research Site
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Hyogo, Japan
- Research Site
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Iwate, Japan
- Research Site
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Kanagawa, Japan
- Research Site
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Miyagi, Japan
- Research Site
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Nagano, Japan
- Research Site
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Nagasaki, Japan
- Research Site
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Nara, Japan
- Research Site
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Okayama, Japan
- Research Site
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Osaka, Japan
- Research Site
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Saitama, Japan
- Research Site
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Shizuoka, Japan
- Research Site
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Tokyo, Japan
- Research Site
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Tottori, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
-Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.
Exclusion Criteria:
-Patients who have no treatment history with the product (i.e.,durvalumab)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
Time Frame: 16weeks
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16weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Toshimitsu Tokimoto, Astrazeneca KK
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D419QC00006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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