A Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC

Prospective, Observational Study of Molecular Residual, Dynamic Monitoring and Recurrence of Stage III Driver Mutated NSCLC

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

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: MRD

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.

• Study Type: Observational
• Enrollment (Estimated): 305

Contacts and Locations

• Study Contact: Name: Ziming Li, M.D.; Phone Number: 8613764590226; Email: liziming1980@hotmail.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • First Affiliated Hospital of Xiamen University
      • Contact: Guojun Geng, M.D.
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Yuan Qiu, M.D.
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Affiliated Cancer Hospital of Harbin Medical University
      • Contact: Yan Yu, M.D.
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Wenxiang Wang, M.D.
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Zhongmin Peng, M.D.
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University
      • Contact: Di Ge, M.D.
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: ziming Li; Phone Number: 8613764590226; Email: liziming1980@hotmail.com
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • Shanxi Cancer Hospital
      • Contact: Weihua Yang, M.D.
    • Xi'an, Shanxi, China
      • Recruiting
      • The First Affiliated Hospital of Xi 'an Jiaotong University
      • Contact: Junke Fu, M.D.
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Qixun Chen, M.D.
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: JIAN HU, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

305 The main research purpose of this project is to associate the MRD status of driver gene positive patients with 12 months of recurrent events. The follow-up is 2 years, so according to the number of patients with stage IIIA NSCLC in each center, and the patient enrollment is planned within 1 year. A total of 305 stage III NSCLC patients were collected

Description

Inclusion Criteria:

1. Patients with stage III non-small cell lung cancer were confirmed by imaging and histological biopsy
2. Age≥ 18
3. ECOG PS:0-1
4. 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
5. 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
6. Provide 20 mL peripheral blood samples periodically
7. 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

Exclusion Criteria:

1. Patients with other malignancies within 5 years
2. According to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival
3. 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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Direct surgery; Stage III NSCLC eligible for direct surgery Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site	Diagnostic test: MRD; MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Neoadjuvant and surgery; 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	Diagnostic test: MRD; MRD（LC-10）include 10 lung cancer-related driver gene mutation site
Chemoradiotherapy; Unresectable Stage III NSCLC eligible for Chemoradiotherapy. Interventions: Diagnostic Test: MRD（LC-10）include 10 lung cancer-related driver gene mutation site	Diagnostic test: MRD; MRD（LC-10）include 10 lung cancer-related driver gene mutation site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of MRD status in driver gene-positive NSCLC patients with 12-month relapse events	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.	2022.12--2025.03

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of MRD status in driver gene-positive NSCLC patients with RFS	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.	2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with OS	Patients are defined as MRD positive if the NGS method detects lung cancer driver gene positivity in the peripheral blood post-surgery.	2022.12--2025.03
Correlation of MRD status in driver gene-positive NSCLC patients with 24-month relapse events	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.	2022.12--2025.03

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Principal Investigator: Shun Lu, M.D., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: ADX-MRD-LC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No