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

NSCLC Clinical Trial

— MRDinS3LC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081777
• Other study ID #: LGH2022144
• Status: Recruiting
• Start date: November 25, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Yuyan Wang
• Phone: 010-88196497
• Email: wangyuyan1219[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Capable of giving signed informed consent, age = 18 and = 80.

2. patients with stage ? 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Locations

Country	Name	City	State
China	Yuyan Wang	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute	Geneplus-Beijing Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (RECIST)	Disease-free survival (RECIST): the survival time from operation or radiation to recurrence	follow-up time: 2 years
Secondary	OS	overall survival from the enrollment to death	follow-up for 2 years
Secondary	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
Secondary	pCR rate of MRD-negative patient	pCR rate of MRD-negative patient	2 years
Secondary	Negative MRD rate in pCR patients	Negative MRD rate in pCR patients	follow-up time: 2 years
Secondary	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