NCT05822284

ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy

The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.

Detailed description

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for next-generation sequencing (NGS) of institutionally-developed 1021-gene panel, and personalized detection panel will be customized based on NGS testing results. Patients will be received induction chemoimmunotherapy followed by surgery or non-surgical treatment in the MDT model and ctDNA-MRD testing will be performed at prespecified time points. For patients who received surgery following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery and landmark time and pulmonary venous blood will be collected intraoperatively. For patients who received non-surgical treatment following induction therapy, peripheral blood will be collected in baseline, 1 day before the third cycle of neoadjuvant therapy, 1 day before non-surgical therapy and landmark time. All included patients will be regularly followed up for at least 5 years.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NGS and ctDNA-MRD detection	NGS and ctDNA-MRD detection

Timeline

• Start date: 2023-04-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2023-04-20
• Last updated: 2023-04-20

Locations

1 site across 1 country: China