IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer

Completed

• Conditions: Carcinoma, Small Cell

• Registration Number: NCT04854590
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study Start: 2021-04-22
• Study First Posted: 2021-04-22
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)	16weeks

Trial Locations

Locations (1)

Research Site; 🇯🇵 Wakayama, Japan