Non-small Cell Lung Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTNGS and ctDNA-MRD detection
NGS and ctDNA-MRD detection
Sponsors
Geneplus-Beijing Co. Ltd.
Second Xiangya Hospital of Central South University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactYan Hu, M.D., Ph.D.
Outcome results
None listed