Construction of a Prognostic and Prediction Model for Perioperative Immunotherapy in NSCLC: A Multi - Omics Perspective

N/ANot Yet RecruitingNCT06856798

Ziming Li120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

NSCLC Stage IIIA/B NSCLC Stage II

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pathological response after immune neoadjuvant therapy

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.

Time frame: From enrollment to surgery at 18 weeks

Secondary Outcomes

2-year Progression-Free Survival(PFS1)

Mainly evaluate the PFS of patients from the time of enrollment until two years later.

Time frame: PFS of patients from the time of enrollment until two years

2-year Progression-Free Survival(PFS2)

Mainly evaluate the patient's PFS from the start of adjuvant immunotherapy to 2 years.

Time frame: PFS from the start of adjuvant immunotherapy to 2 years.