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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03643484
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Study Start: 2018-10-24
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan