IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy
IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer Who Are Treated With Maintenance Therapy After Definitive Chemoradiation Therapy.
1 other identifier
observational
634
1 country
37
Brief Summary
To investigate the impact of presence/absence or grade of radiation pneumonitis before starting IMFINZI, on the onset of interstitial lung disease (including radiation pneumonitis) after starting IMFINZI, in the real world in patients with locally advanced unresectable non-small cell lung cancer who are treated with the product as maintenance therapy after definitive chemoradiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
October 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedFebruary 21, 2024
February 1, 2024
2.7 years
August 21, 2018
February 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade)
12 months
Eligibility Criteria
Patients with locally advanced unresectable non-small cell lung cancer after definitive chemoradiation therapy
You may qualify if:
- Patients with locally advanced unresectable non-small cell lung cancer who are treated with IMFINZI for the first time as maintenance therapy after definitive chemoradiation therapy
You may not qualify if:
- No past history of hypersensitivity to the components of IMFINZI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Aichi, D4194C00003, Japan
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Akita, D4194C00003, Japan
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Aomori, D4194C00003, Japan
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Chiba, D4194C00003, Japan
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Fukuoka, D4194C00003, Japan
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Fukushima, D4194C00003, Japan
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Gifu, D4194C00003, Japan
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Gunma, D4194C00003, Japan
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Hiroshima, D4194C00003, Japan
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Hokkaido, D4194C00003, Japan
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Hyōgo, D4194C00003, Japan
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Ibaraki, D4194C00003, Japan
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Ishikawa, D4194C00003, Japan
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Ishikawa, Japan
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Kagawa, D4194C00003, Japan
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Kanagawa, D4194C00003, Japan
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Kumamoto, D4194C00003, Japan
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Kyoto, D4194C00003, Japan
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Mie, D4194C00003, Japan
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Miyagi, D4194C00003, Japan
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Miyazaki, D4194C00003, Japan
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Nagano, D4194C00003, Japan
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Nagasaki, D4194C00003, Japan
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Nara, D4194C00003, Japan
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Niigata, D4194C00003, Japan
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Okayama, D4194C00003, Japan
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Osaka, D4194C00003, Japan
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Saitama, D4194C00003, Japan
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Shiga, D4194C00003, Japan
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Shizuoka, D4194C00003, Japan
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Tochigi, D4194C00003, Japan
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Tokyo, D4194C00003, Japan
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Tottori, D4194C00003, Japan
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Toyama, D4194C00003, Japan
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Yamagata, D4194C00003, Japan
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Yamaguchi, D4194C00003, Japan
Research Site
Yamanashi, D4194C00003, 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
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 22, 2018
Study Start
October 24, 2018
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
February 21, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share