ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy
|
Diagnostic Test: NGS and ctDNA-MRD detection
NGS and ctDNA-MRD detection
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Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histopathology or cytology confirmed the non-small cell lung cancer
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Age ranging from 18 to 75
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Agree to participate in this study and sign an informed consent form
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Treatment-naive tumor
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Driver gene negativity
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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
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The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1
Exclusion Criteria:
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Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
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Small cell lung cancer
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Driver gene positivity
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Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy
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Patients with solid organ or blood system transplantation
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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
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Patients with interstitial lung disease
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Patients with acute or chronic infectious disease
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Pregnant and lactating women
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Patients who have undergone other clinical drug trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China | Changsha | Hunan | China | 410011 |
Sponsors and Collaborators
- Second Xiangya Hospital of Central South University
- Geneplus-Beijing Co. Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LYF2023026