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

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

NCT ID: NCT05822284

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Study type: Observational

Overall status: Not yet recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: NGS and ctDNA-MRD detection
Description: NGS and ctDNA-MRD detection
Arm group label: Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy

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.

Criteria for eligibility:

Study pop:
Potentially resectable stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Histopathology or cytology confirmed the non-small cell lung cancer - Age ranging from 18 to 75 - Agree to participate in this study and sign an informed consent form - Treatment-naive tumor - Driver gene negativity - According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor - The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1 Exclusion Criteria: - Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form - Small cell lung cancer - Driver gene positivity - Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy - Patients with solid organ or blood system transplantation - Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors - Patients with interstitial lung disease - Patients with acute or chronic infectious disease - Pregnant and lactating women - Patients who have undergone other clinical drug trials

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China

Address:
City: Changsha
Zip: 410011
Country: China

Contact:
Last name: Yan Hu, M.D., Ph.D.
Email: yanhu@csu.edu.cn

Start date: April 2023

Completion date: March 2029

Lead sponsor:
Agency: Second Xiangya Hospital of Central South University
Agency class: Other

Collaborator:
Agency: Geneplus-Beijing Co. Ltd.
Agency class: Industry

Source: Second Xiangya Hospital of Central South University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05822284