Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer (MRDinS3LC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Yuyan Wang; Phone Number: 010-88196497; Email: wangyuyan1219@aliyun.com
• Study Contact Backup: Name: Han Yin; Phone Number: 01088196084

Study Locations

• China
  • Beijing, China, 100142
    • Recruiting
    • Yuyan Wang
    • Contact: Han Yin
    • Contact: Bo Jia

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.

Description

Inclusion Criteria:

1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.
5. 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:

1. patients suffering from other malignant tumors.
2. patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
3. Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
4. Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Arms1：For stage III NSCLC patients who underwent complete resection.; 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.; 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?

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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute
• Collaborators: Geneplus-Beijing Co. Ltd.
• Investigators: Principal Investigator: Yuyan Wang, doctorate, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: MRD, potentially resectable NSCLC, stage III
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LGH2022144

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