A Prospective Study of Comprehensive Geriatric Assessment (CGA) in Non-Small Cell Lung Cancer Patients (NSCLC) Undergoing Treatment With Immune Checkpoint Inhibitors.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Nature of irAEs at 3 months.
研究概览
简要总结
Lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for the biggest subtype of lung cancer. In recent years, the use of immunotherapy has revolutionised the management of NSCLC, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. Despite this, doubts remain regarding the true efficacy of immunotherapy in patients > 75 years old, given that this age subgroup is mis-represented in prospective phase III trials, in terms of numbers and baseline functional status, compared to real-world experience.
Furthermore, the use of immune checkpoint inhibitors (ICIs) is associated with a spectrum of immune-related adverse events (irAEs), affecting a range of organ systems. Once again, there are doubts about the safety of the use of these agents in patients > 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup.
Comprehensive Geriatric Assessment (CGA) and the vulnerable elders survey (VES-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. This study therefore aims to prospectively examine patients > 70 years old with a diagnosis of NSCLC, commencing immunotherapy. It will assess CGA and VES-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. In doing so, it will help to determine if CGA and VES-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥70 years old with advanced NSCLC due to start first or second line ICI therapy.
- •Patients able to give informed consent.
排除标准
- •Patients already on treatment with ICIs.
- •Patients with CNS or leptomeningeal spread / disease progression.
- •ECOG performance status III/IV.
- •Patients with severe autoimmune diseases.
- •Patients who are recruited and then stop treatment after receiving ≤3 cycles of ICI therapy, secondary to disease progression.
结局指标
主要结局
Nature of irAEs at 3 months.
时间窗: At 3 months after entering the study.
Incidence of irAEs at 6 months.
时间窗: At 6 months after entering the study.
Incidence of irAEs at 3 months.
时间窗: At 3 months after entering the study.
Grading of irAEs at 3 months.
时间窗: At 3 months after entering the study.
Nature of irAEs at 6 months.
时间窗: At 6 months after entering the study.
Grading of irAEs at 6 months.
时间窗: At 6 months after entering the study.
次要结局
- Death within 30 days (if applicable).(Within 30 days of entering the study.)
- Incidence of re-admission into hospital at 3 months.(At 3 months after entering the study.)
- Incidence of re-admission into hospital at 6 months.(At 6 months after entering the study.)
- Duration of inpatient stay (conditional on re-admission into hospital).(Up to 12 months after entering the study.)