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NCT04854590 Clinical Trial

IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

Carcinoma, Small Cell Clinical Trial

Official title:
IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04854590
Other study ID # D419QC00006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 22, 2021
Est. completion date August 31, 2023

Study information
Verified date September 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

Description:

To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.

Recruitment information / eligibility
Status Completed
Enrollment 248
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Chiba
Japan Research Site Fukuoka
Japan Research Site Gunma
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Iwate
Japan Research Site Kanagawa
Japan Research Site Miyagi
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade) 16weeks
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