The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,270
- 试验地点
- 1
- 主要终点
- Cohort 1 & 5: Progression-free survival (PFS)
研究概览
简要总结
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.
详细描述
This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 5 cohorts
- Cohort 1: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of ICIs in advanced NSCLC.
- Cohort 2: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC.
- Cohort 3: A prospective, observational cohort study to explore the association between sleep disturbance and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC.
- Cohort 4: A prospective, observational cohort study to explore the association of sleep disturbance with postoperative recurrence and prognosis in early-stage NSCLC receiving radical surgery.
- Cohort 5: A prospective observational cohort study to explore the association between sleep disturbance and the efficacy of first-line treatment of targeted therapy in advanced NSCLC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Histologically confirmed diagnosis of NSCLC;
- •Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;
- •Treatment naïve;
- •Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed consent to participate in the study;
排除标准
- •Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) fusion and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- •Presence of other malignant tumors or malignant diseases within 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Patients receiving sleep medication;
- •Prior participation in other clinical drug trials;
- •Symptomatic brain metastasis;
- •Inability to complete scale assessments.
- •Inclusion Criteria:
- •Age ≥ 18 years old;
- •Histologically confirmed diagnosis of SCLC；
- •Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
- •ECOG PS of 0-1;
- •Treatment naïve;
- •Presence of at least one measurable lesion according to the RECIST v1.1 ;
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed consent to participate in the study;
- •Exclusion Criteria:
- •Presence of other malignant tumors or malignant diseases within 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Patients receiving sleep medication;
- •Prior participation in other clinical drug trials;
- •Symptomatic brain metastasis;
- •Inability to complete scale assessments.
- •Inclusion Criteria:
- •Age ≥18 years old;
- •Pathologically diagnosed as NSCLC;
- •Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
- •At least one measurable lesion can be evaluated according to the RECIST v1.1;
- •Treatment naïve;
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;
- •Cardiopulmonary function can withstand surgery;
- •Informed consent to participate in the study.
- •Exclusion Criteria:
- •EGFR-sensitizing mutation and/or ALK fusion and/or ROS1 fusion-positive;
- •Presence of other malignant tumors or malignant diseases within 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Patients receiving sleep medication;
- •Prior participation in other clinical drug trials;
- •Symptomatic brain metastasis;
- •Inability to complete scale assessments.
- •Inclusion Criteria:
- •Age ≥ 18 years old;
- •Pathologically diagnosed as NSCLC;
- •Pathologically stage confirmed as early stage of IA-IIIA;
- •Available for tumor tissue samples;
- •Treatment naïve;
- •Receiving radical surgery;
- •Informed consent to participate in the study;
- •Exclusion Criteria:
- •Presence of other malignant tumors or malignant diseases within 3 years;
- 另有 21 项未显示
结局指标
主要结局
Cohort 1 & 5: Progression-free survival (PFS)
时间窗: 3 years
Time from the beginning of first-line immunotherapy or targeted therapy to the first progression (PD).
Cohort 2: Overall survival (OS)
时间窗: 5 years
Duration from the beginning of first-line immunotherapy until death due to any cause. Subjects who are still alive at the end of the study observation period will be censored at the time of last known vital status.
Cohort 3: Event-free survival (EFS)
时间窗: 3 years
Time from the start of initial treatment of immunotherapy to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death.
Cohort 4: Disease-free survival (DFS)
时间窗: 5 years
Duration between the date after surgery to the date of any recurrence or death firstly.
次要结局
- Cohort 2: Progression-free survival (PFS)(3 years)
- Cohort 3: Pathologic complete response (pCR) rate(3 years)
- Cohort 1 & 3 & 4 & 5: Overall survival (OS)(5 years)
- Quality of life (QoL)(5 years)
- Cohort 3: Major pathologic response (MPR)(3 years)
- Cohort 1 & 2 & 5: Objective Response Rate (ORR)(2 years)
研究者
Fang Wu
Professor
Second Xiangya Hospital of Central South University