A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Diagnostic Test: MRD
- Registration Number
- NCT06443684
- Lead Sponsor
- Shanghai Chest Hospital
- Brief Summary
The goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage III NSCLC for disease recurrence and prognosis assessment. The main question it aims to answer is:
1) Whether MRD(Minimal residual disease) status can predict recurrence events in stage III driven-mutant NSCLC in advance
- Detailed Description
Non-small cell lung cancer in stage III (IIIa, IIIIb, IIIc) has a low survival rate, and the 5-year survival rate of stage III patients is less than 30%. In clinical studies of non-small cell lung cancer operable stage III driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy.
The tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. Early the domestic large lung cancer MRD((Minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of MRD high negative predictive value defined the potential cure population, found that postoperative MRD negative population could not benefit from adjuvant therapy, clarify the existence of preoperative Non-shedding tumor does not affect postoperative MRD monitoring, and exploring the stage II / III MRD turn high risk of postoperative lung cancer. Therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 305
- Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
- Age≥ 18
- ECOG PS:0-1
- Tumor molecular testing by EBUS or biopsy confirmed positive for one or more of the following driver genes:EGFR\ALK\ROS1\RET\KRAS\PIK3CA\BRAF\HER2\MET
- Patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject
- Provide 20 mL peripheral blood samples periodically
- The subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up
- Patients with other malignancies within 5 years
- According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
- The subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neoadjuvant and surgery MRD Stage III NSCLC eligible for neoadjuvant therapy followed by surgery Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site Direct surgery MRD Stage III NSCLC eligible for direct surgery Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site Chemoradiotherapy MRD Unresectable Stage III NSCLC eligible for Chemoradiotherapy. Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site
- Primary Outcome Measures
Name Time Method Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events 2022.12--2025.03 Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
- Secondary Outcome Measures
Name Time Method Correlation of MRD status in driver gene-positive NSCLC patients with RFS 2022.12--2025.03 Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events 2022.12--2025.03 Patients are defined as MRD positive if lung cancer driver genes are detected in peripheral blood post-surgery using NGS methods, and radiological recurrence is based on RECIST 1.1 criteria.
Correlation of MRD status in driver gene-positive NSCLC patients with OS 2022.12--2025.03 Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery.
Trial Locations
- Locations (11)
Affiliated Cancer Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Shandong Provincial Hospital
🇨🇳Jinan, Shandong, China
Shanghai Chest hospital
🇨🇳Shanghai, Shanghai, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanxi Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi 'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China