NSCLC Stage II, NSCLC Stage IIIA/B
Conditions
Keywords
Multi - Omics Biomarkers, Immunotherapy, Perioperative, ctDNA, MRD
Brief summary
This research focuses on exploring biomarkers for the application of PD - 1/PD - L1 immune checkpoint inhibitors in the perioperative immunotherapy of lung cancer. Multi - index tests are conducted on tissues prior to treatment, as well as blood samples at baseline and during the treatment course. The goal is to identify biomarkers capable of predicting the efficacy of neoadjuvant and adjuvant immunotherapies. Additionally, by integrating these multiple - index data into models, patients are to be stratified based on their potential benefits from perioperative immunotherapy, providing personalized guidance for clinical decision - making.
Interventions
None listed
Sponsors
Ziming Li
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* NSCLC, clinical tumor stage II-IIIB * Without EGFR/ALK gene mutation * Patient 18 years or older. * Scheduled for neoadjuvant immunotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 * Life expectancy ≥ 12 weeks. * Patient able to understand and sign written informed consent.
Exclusion criteria
* With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence). * With history of chemotherapy or radiotherapy (including pre - operative and post - operative adjuvant chemotherapy and radiotherapy) or systemic anti - tumor treatment. * with autoimmune diseases unsuitable for PD - 1 monoclonal antibody treatment, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain - Barré syndrome, or multiple sclerosis. * Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response after immune neoadjuvant therapy | From enrollment to surgery at 18 weeks | The primary evaluation indicators are pathological complete response (pCR) and major pathological response (MPR). MPR refers to the residual tumor cells in the surgically resected specimens being ≤ 10%, while pCR requires the complete disappearance of tumor cells. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Progression-Free Survival(PFS1) | PFS of patients from the time of enrollment until two years | Mainly evaluate the PFS of patients from the time of enrollment until two years later. |
| 2-year Progression-Free Survival(PFS2) | PFS from the start of adjuvant immunotherapy to 2 years. | Mainly evaluate the patient's PFS from the start of adjuvant immunotherapy to 2 years. |
Contacts
Primary ContactZiming Li
Outcome results
None listed