A Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
研究概览
简要总结
Durvalumab was approved in the Russian Federation for use after both concurrent and subsequent CRT until disease progression. Currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. Moreover, generation data on the safety and real world effectiveness of durvalumab after concurrent chemo-radiation therapy (cCRT) and subsequent chemo-radiation therapy (sCRT) in routine practice in the Russian Federation will be of high relevance.
The other important question that needs to be addressed is the duration of treatment with durvalumab and its' influence on the relevant outcomes. According to the Russian label, it is possible to continue treatment with durvalumab until disease progression, although current data from the PACIFIC trial provide the results on 12 months duration of durvalumab treatment. The real-world data about the duration of treatment with durvalumab in the Russian population and its' influence on various outcomes would be very important.
Among other goals, the current study is aimed to analyze factors influencing the effectiveness of durvalumab therapy in the real-world setting (e.g. duration of treatment, delays in the start of treatment with durvalumab after CRT over, early discontinuation due to any factors including AEs, etc.). The study also aims to elucidate treatment approaches after discontinuation from durvalumab (post-progression outcomes and treatment in case of discontinuation due to AEs). This study will support the understanding of described factors and will take and an attempt to optimize the treatment process to improve outcomes for patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 are eligible to be included in the study only if all of the following inclusion criteria and none of the
排除标准
- •Written informed consent obtained from the patient prior to performing any protocol-related procedures
- •Age ≥18 years at time of study entry
- •Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 8)
- •Patients must have completed a platinum-based chemotherapy with radiation therapy (concurrent or sequential) without evidence of disease progression
- •Patients must have been treated with at least one dose of durvalumab
- •Exclusion Criteria:
- •Any subject who meets any of the following criteria will not qualify for entry into the study:
- •Absence or missing of written informed consent form
- •Patients treated with durvalumab in clinical studies
- •Absence of essential data to obtain all necessary information
- •Confirmation that the subject was already included in this study before
结局指标
主要结局
Safety of durvalumab in patients with unresectable locally advanced NSCLC without progression after CRT in routine practice of the Russian Federation.
时间窗: Up to 54 month
Number of AEs which lead to discontinuation
时间窗: Up to 54 month
Distribution of pneumonitis grades
时间窗: Up to 54 month
Nature of pneumonitis by physician diagnosis [radiation or immune-related]
时间窗: Up to 54 month
Number of AESIs
时间窗: Up to 54 month
Time to pneumonitis [median, months]
时间窗: Up to 54 month
Duration of pneumonitis [median, months]
时间窗: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation.
时间窗: Up to 54 month
Number of any treatment (durvalumab) related AEs by physician diagnosis within all treatment period plus 3 months after durvalumab discontinuation separately for fix dose (1500mg every 4 weeks) and 10mg/kg every 2 weeks dosage.
时间窗: Up to 54 month
Number of irAEs
时间窗: Up to 54 month
Number of SAEs
时间窗: Up to 54 month
Number of grade 3-4 AEs
时间窗: Up to 54 month
Number of post discontinuation irAEs
时间窗: Up to 54 month
次要结局
未报告次要终点