Advanced Lung Non-Small Cell Carcinoma
Conditions
Keywords
ctDNA, advanced lung cancer, first-line immunotherapy, the risk of progression, minimal residual disease (MRD), long-term benefit
Brief summary
This study aims to explore the correlation of circulating tumor DNA(ctDNA) and the risk of progression in patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months)
Detailed description
Evidence suggests that circulating tumor DNA (ctDNA) analysis can noninvasively identify minimal residual disease (MRD) in clinical oncology. The researches will be sharply increased about ctDNA potential clinical application in the near future. In the early stage of NSCLC, ctDNA has been indicated to identify those at high risk of recurrence after radical surgery. And this study will focus on those patients with advanced NSCLC who have long-term benefit from first-line immunotherapy (PFS 12 months). 20ml plasma will be collected concurrently with the imaging examination. Meanwhile, the investigators would like to explore the lead time of detectable ctDNA before regular imaging finding.
Interventions
DIAGNOSTIC_TESTctDNA detection
High-depth sequencing method is used to detecting ctDNA.
Sponsors
Hengyang Central Hospital
Xiangtan Central Hospital
Hunan University of Medicine General Hospital
Hunan Provincial People's Hospital
Fang Wu
Sun Yat-Sen University Cancer Center
First Affiliated Hospital Xi'an Jiaotong University
Fujian Cancer Hospital
Third Affiliated Hospital of Third Military Medical University
Xiangya Hospital of Central South University
Qinghai Province Fifth People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhejiang Provincial People's Hospital
Hunan Cancer Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Second Affiliated Hospital, Zhejiang University, School of Medicine
Zhejiang Cancer Hospital
The First Affiliated Hospital of Guangzhou Medical University
Inner Mongolia People's Hospital
Guizhou Provincial People's Hospital
The Third Xiangya Hospital of Central South University
Yueyang Central Hospital
ZhuZhou Central Hospital
Zhangjiajie Affiliated Hospital of Hunan Normal University
Loudi Central Hospital
Cancer Hospital of Guangxi Medical University
First Affiliated Hospital of Kunming Medical University
The Affiliated Hospital of Inner Mongolia Medical University
Changsha Central Hospital
Hunan Provincial Hospital of Traditional Chinese Medicine
Yiyang Central Hospital
Shaoyang Central Hospital
Jiangsu Cancer Institute & Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital of Xinjiang Medical University
Renmin Hospital of Wuhan University
Changsha First Hospital
The Second People's Hospital of Huaihua
The First People's Hospital of Xiangtan City
Xiangxi Autonomous Prefecture People's Hospital
Chenzhou NO. 1 people's Hospital
Xiangya Changde Hospital
Wuhan TongJi Hospital
The Third Hospital of Changsha
Yongzhou Center Hospital
Liaoning Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Advanced non-small cell lung cancer (stage IIIB-IV), pathological types limited to squamous cell carcinoma or non-squamous cell carcinoma, driver gene mutations (EGFR/ALK/ROS1) were negative * General condition: ECOG score 0 or 1 * First-line monotherapy or combination immunotherapy * The long-term benefit of immunotherapy was defined as PFS=12months * Tumor tissue samples can be obtained at the time of enrollment, and at least 5 \~ 10 sections can be generated, and the pathological report indicates that the overall tumor content is not less than 10% or NGS testing with a fixed-panel is available; or no tumor tissue is available. * At least one measurable lesion (except patients with CR after first-line treatment) can be evaluated according to RECIST1.1 standard. * Have self-awareness, be able to understand the research scheme and voluntarily participate in the study, and can sign the informed consent form * Have good compliance, be able to cooperate with the collection of specimens from each node and provide corresponding clinical information.
Exclusion criteria
* Serious primary diseases of the heart, liver and kidney * Other malignant tumors within 3 years prior to diagnosis of NSCLC * Women in pregnancy and lactation * The active stage of human immunodeficiency virus (HIV) infection * Patients with active systemic infection, pneumonia, tuberculosis, pericarditis * Patients who cannot understand the content of the experiment and cannot cooperate and refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 3 years | The duration from study enrollment to disease progression or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The correlation of ctDNA and risk of progression | 3 years | The correlation of ctDNA and risk of progression during the erolled observation process |
| Lead time | 3 years | Lead time defined as the interval between ctDNA detection and imaging of progression. |
| Incidence of adverse events | 3 years | the incidence of adverse events during the whole observation time |
| Overall survival (OS) | 5 years | Overall survival (OS) defined as the duration from study enrollment 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. |
Countries
China
Outcome results
None listed