A Prospective, Observational, Multicenter, Post Marketing Surveillance Study to Assess Safety of Durvalumab in Indian Adult Patients With Resectable Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 78
- 主要终点
- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
研究概览
简要总结
This will be a single-arm, multicenter, prospective, observational, real-world study and the data source is the patients' medical record at each site. A total of 78 patients will be enrolled in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed previously untreated resectable NSCLC (tumors ≥ 4 cm and/or node positive) and no known EGFR mutations or ALK rearrangements prescribed with durvalumab as per local prescriber information.
- •Provision of signed, written and dated informed consent
排除标准
- •Presence of unresectable or metastatic disease.
- •Prior treatment with durvalumab for any other indications
- •Requires concurrent treatment for cancers other than resectable NSCLC
- •Concurrently participating in any other clinical trial
- •Patients with active or prior autoimmune disease or with medical conditions that required systemic corticosteroids or immunosuppressants
- •Any condition that, in the opinion of the investigator, would interfere with the patient's participation in the study.
结局指标
主要结局
Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)*
时间窗: 21 months
\- Frequency and proportion of patients with Grade 3/4 possibly related adverse events (PRAEs)\*
Frequency and proportion of patients with treatment emergent adverse events (TEAE) & serious adverse events (SAEs), , mortality.
时间窗: 21 months
Frequency and proportion of patients with treatment emergent adverse events (TEAE) \& serious adverse events (SAEs), , mortality.
Time to occurrence of first AEs and first SAEs
时间窗: 21 months
Time to occurrence of first AEs and first SAEs
* PRAEs as assessed per the WHO-UMC criteria
时间窗: 21 months
\* PRAEs as assessed per the WHO-UMC criteria
次要结局
未报告次要终点