Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of participants with paired samples of blood and viable tissue
研究概览
简要总结
This study aims to determine if it is feasible to collect samples of blood and viable lung cancer tissue in patients with either:
- Stage IV mutation-driven NSCLC
- Stage II-III NSCLC undergoing neoadjuvant immunotherapy prior to surgery
Viable tissue has been defined by the collaborating pathology department as the presence of viable tumour cells, in accordance with recommendations from the International Association or the Study of Lung Cancer.
In patients with stage IV NSCLC, obtaining adequate samples of viable tissue for advanced testing can be challenging, as sites of cancer that are accessible by biopsy are often small, and contain few viable cancer cells. If obtained, however, viable blood and tissue specimens can be utilised for genetic and other analyses aimed at identifying cancer markers that may offer prognostic information, or that may potentially lead to development of therapies that target these markers in the future.
In patients with stage II-III NSCLC, the use of immunotherapy prior to surgery has been shown to affect the proportion of viable tumour tissue at the time of surgery, although this needs to be further studied. There is a need to better understand the genetic basis of these tumours to improve response rates to immunotherapy prior to surgery.
The study will be open for four years in total. The first three years will consist of recruitment and participant follow up, and the fourth year will consist of follow up only. Data analysis will occur in the fifth year when the study is closed.
详细描述
Rationale Benchmarking the proportion of patients who are able to provide paired samples of blood and viable tumour tissue is important in oncogene-addicted metastatic NSCLC patients as investigators have now entered the era of genotype-guided post-progression targeted therapies. In the early-stage operable NSCLC context, benchmarking the feasibility of paired samples is of interest as neoadjuvant CPI-based therapy has recently emerged as a new standard of care strategy.
As such, investigators have defined the following cohorts within our study:
Cohort 1: Oncogene-addicted NSCLC, due to commence new line of targeted therapy
- Sub-cohort 1A: treatment naïve, oncogene-addicted NSCLC
- Sub-cohort 1B: pre-treated, oncogene-addicted NSCLC, received prior targeted therapy
- Sub-cohort 1C: pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI) Cohort 2: Early-stage operable NSCLC undergoing neoadjuvant CPI therapy
Primary aim
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 未提供
排除标准
- •Patient too medically unstable to commit to sampling required for the study
结局指标
主要结局
The number of participants with paired samples of blood and viable tissue
时间窗: 5 years
The number of participants with paired samples of blood and viable tissue with: * Oncogene-addicted metastatic NSCLC commencing new line of targeted therapy at progression (Cohort 1), and * Early-stage operable NSCLC undergoing neoadjuvant CPI-based therapy (Cohort 2) Viable tissue is defined by the presence of viable tumour cells. Viable tumour cells are defined by those with well-preserved architectural and cytological features, in line with the latest recommendation from the International Association for the Study of Lung Cancer (IASLC), evaluated by a specialist pulmonary pathologist using a haematoxylin \& eosin (H\&E) stained slide.
次要结局
- The number of patients with viable tissue samples(5 years)