Second Xiangya Hospital of Central South University
Phase
Observational
Started
2023-04
Last updated
2023-04-20
Condition(s) studied
Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
NGS and ctDNA-MRD detection
NGS and ctDNA-MRD detection: NGS and ctDNA-MRD detection
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Predicting Progression Free Survival — up to 5 years Ability of dynamic ctDNA-MRD assessment to predict progression-free survival (PFS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy
Predicting pathologic complete response — Up to 1 year Ability of dynamic ctDNA-MRD assessment to predict pathologic complete response (pCR) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery
Predicting Overall Survival — up to 5 years Ability of dynamic ctDNA-MRD assessment to predict overall survival (OS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy
Trial sites (1)
Facility
City
Region
Status
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
Changsha
Hunan
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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