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临床试验/NCT03643484
NCT03643484已完成不适用

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.

AstraZeneca1 个研究点 分布在 1 个国家目标入组 634 人开始时间: 2018年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
634
试验地点
1
主要终点
Incidence of Interstitial lung disease (including radiation pneumonitis) by post-chemoradiation therapy radiation pneumonitis (yes/no) and by severity (CTCAE grade)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • No past history of hypersensitivity to the components of IMFINZI

结局指标

主要结局

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

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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