ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Diagnostic Test: NGS and ctDNA-MRD detection
- Registration Number
- NCT05822284
- Lead Sponsor
- Second Xiangya Hospital of Central South University
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy NGS and ctDNA-MRD detection -
- Primary Outcome Measures
Name Time Method 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
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 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
- Secondary Outcome Measures
Name Time Method Objective response rate(ORR) Up to 1 year The proportion of patients achieved complete or partial remission according to RECIST 1.1 prior to definitive surgery.
Adverse events (AEs) Up to 5 years Number of patients experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Perioperative complications rate Up to 3 years Number of patients experiencing perioperative complications will be recorded.
Health-related Quality of Life Up to 5 years Health-related Quality of Life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0.
Perioperative pain evaluation Up to 3 years Perioperative pain evaluation assessed by a numeric rating scale (NRS). A total of 11 points from 0 to 10 are used to describe the pain intensity. 0 means no pain, the number of points increases when the pain is stronger, and 10 means the most intense pain.
Lung cancer-related Quality of Life Up to 5 years Health-related Quality of Life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire in Lung Cancer.
Trial Locations
- Locations (1)
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
🇨🇳Changsha, Hunan, China