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

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: NSCLC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06081777

LGH2022144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

65 participants in 2 patient groups

Arms1：For stage III NSCLC patients who underwent complete resection.

Description:

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.

Description:

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