Dynamic Monitoring of MRD in Neoadjuvant Chemoimmunotherapy for Resectable Stage II-IIIB Non-small Cell Lung Cancer:An Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate,event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.

• Have previously untreated and histological examination confirms resectable stage II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNM staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 should be negative for non-squamous non-small cell lung cancer

• Adequate organ function and expected survival time ≥ 12 weeks;

• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Locations
Other Locations
China
The First Hospital Of Jilin University
RECRUITING
Changchun
Contact Information
Primary
Kewei Ma
makw@jlu.edu.cn
0431-88782179
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2025-12-17
Participants
Target number of participants: 20
Treatments
immunotherapy and chemotherapy
Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery.
Sponsors
Leads: The First Hospital of Jilin University

This content was sourced from clinicaltrials.gov