Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.

Detailed Description
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In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.

Official Title
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A Study Evaluating MRD Biomarker in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

Conditions
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NSCLC

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving signed informed consent, age ≥ 18 and ≤ 80. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities. No driving gene EGFR/ALK mutation. PS = 0-1. the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development. Exclusion Criteria: patients suffering from other malignant tumors. patients change the treatment regimen before receiving the specified treatment or before the disease progresses. Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period; Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arms1：For stage III NSCLC patients who underwent complete resection.<br>Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery (if any), adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis | |
| Arms 2：For stage III NSCLC patients who underwent concurrent radio-chemotherapy.<br>Immunotherapy alone or chemotherapy combined with immunotherapy. Collect patients' baseline puncture tissues, peripheral blood samples from multiple nodes after new adjuvant treatment, surgery, adjuvant treatment, and follow-up, and carry out for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. Assigned Interventions：1021-MRD analysis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival (RECIST) | Disease-free survival (RECIST)： the survival time from operation or radiation to recurrence | follow-up time: 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival from the enrollment to death | follow-up for 2 years | 
| The prediction of recurrence by positive MRD | Whether the prediction of recurrence by positive MRD is earlier than that confirmed by clinical diagnosis. | follow-up for 2 years | 
| pCR rate of MRD-negative patient | pCR rate of MRD-negative patient | 2 years | 
| Negative MRD rate in pCR patients | Negative MRD rate in pCR patients | follow-up time: 2 years | 
| 2-year DFS of ctDNA-negative patients in operation group / inoperable group | 2-year DFS of ctDNA-negative patients in operation group / inoperable group | follow-up time: 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRD, potentially resectable NSCLC, stage III