IMFINZI Specific-Clinical Experience Investigation in Patients With NSCLC After Definitive Chemoradiation Therapy

February 20, 2024 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

634

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan, D4194C00003
        • Research Site
      • Akita, Japan, D4194C00003
        • Research Site
      • Aomori, Japan, D4194C00003
        • Research Site
      • Chiba, Japan, D4194C00003
        • Research Site
      • Fukuoka, Japan, D4194C00003
        • Research Site
      • Fukushima, Japan, D4194C00003
        • Research Site
      • Gifu, Japan, D4194C00003
        • Research Site
      • Gunma, Japan, D4194C00003
        • Research Site
      • Hiroshima, Japan, D4194C00003
        • Research Site
      • Hokkaido, Japan, D4194C00003
        • Research Site
      • Hyogo, Japan, D4194C00003
        • Research Site
      • Ibaraki, Japan, D4194C00003
        • Research Site
      • Ishikawa, Japan
        • Research Site
      • Ishikawa, Japan, D4194C00003
        • Research Site
      • Kagawa, Japan, D4194C00003
        • Research Site
      • Kanagawa, Japan, D4194C00003
        • Research Site
      • Kumamoto, Japan, D4194C00003
        • Research Site
      • Kyoto, Japan, D4194C00003
        • Research Site
      • Mie, Japan, D4194C00003
        • Research Site
      • Miyagi, Japan, D4194C00003
        • Research Site
      • Miyazaki, Japan, D4194C00003
        • Research Site
      • Nagano, Japan, D4194C00003
        • Research Site
      • Nagasaki, Japan, D4194C00003
        • Research Site
      • Nara, Japan, D4194C00003
        • Research Site
      • Niigata, Japan, D4194C00003
        • Research Site
      • Okayama, Japan, D4194C00003
        • Research Site
      • Osaka, Japan, D4194C00003
        • Research Site
      • Saitama, Japan, D4194C00003
        • Research Site
      • Shiga, Japan, D4194C00003
        • Research Site
      • Shizuoka, Japan, D4194C00003
        • Research Site
      • Tochigi, Japan, D4194C00003
        • Research Site
      • Tokyo, Japan, D4194C00003
        • Research Site
      • Tottori, Japan, D4194C00003
        • Research Site
      • Toyama, Japan, D4194C00003
        • Research Site
      • Yamagata, Japan, D4194C00003
        • Research Site
      • Yamaguchi, Japan, D4194C00003
        • Research Site
      • Yamanashi, Japan, D4194C00003
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced unresectable non-small cell lung cancer after definitive chemoradiation therapy

Description

Inclusion Criteria:

-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

Exclusion Criteria:

-No past history of hypersensitivity to the components of IMFINZI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4194C00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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