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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443684
• Other study ID #: ADX-MRD-LC
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: Shanghai Chest Hospital
• Contact: Ziming Li, M.D.
• Phone: 8613764590226
• Email: liziming1980[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 305
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non Small Cell Lung Cancer
• Recurrence

Intervention

Diagnostic Test:
• MRD
MRD(LC-10)include 10 lung cancer-related driver gene mutation site

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
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	First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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