The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Predicting Overall Survival
研究概览
简要总结
The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.
详细描述
This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (NGS) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on NGS testing results. Patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the MDT model and ctDNA-MRD testing will be performed at prespecified time points. For patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. For patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. All included patients will be regularly followed up for at least 5 years.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathology or cytology confirmed the non-small cell lung cancer
- •Age ranging from 18 to 75
- •Agree to participate in this study and sign an informed consent form
- •Treatment-naive tumor
- •Driver gene negativity
- •According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor
- •The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1
排除标准
- •Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
- •Small cell lung cancer
- •Driver gene positivity
- •Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
- •Patients with solid organ or blood system transplantation
- •Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors
- •Patients with interstitial lung disease
- •Patients with acute or chronic infectious disease
- •Pregnant and lactating women
- •Patients who have undergone other clinical drug trials
结局指标
主要结局
Predicting Overall Survival
时间窗: up to 5 years
Ability of dynamic ctDNA-MRD assessment to predict overall survival (OS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy
Predicting pathologic complete response
时间窗: Up to 1 year
Ability of dynamic ctDNA-MRD assessment to predict pathologic complete response (pCR) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery
Predicting Progression Free Survival
时间窗: up to 5 years
Ability of dynamic ctDNA-MRD assessment to predict progression-free survival (PFS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy
次要结局
- Objective response rate(ORR)(Up to 1 year)
- Adverse events (AEs)(Up to 5 years)
- Perioperative complications rate(Up to 3 years)
- Health-related Quality of Life(Up to 5 years)
- Perioperative pain evaluation(Up to 3 years)
- Lung cancer-related Quality of Life(Up to 5 years)
研究者
Liu Wenliang
Professor
Second Xiangya Hospital of Central South University