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

Launched by ZIMING LI · Mar 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to improve treatment for patients with non-small cell lung cancer (NSCLC) at stages II to IIIA/B by studying how certain biological markers can help predict how well new immune therapies work. These therapies, known as PD-1/PD-L1 inhibitors, are designed to help the body’s immune system fight cancer. Researchers will take samples from patients’ tumors and blood before treatment starts and during the treatment period to find out which patients are most likely to benefit from these therapies. The ultimate goal is to create personalized treatment plans based on these findings.

To be eligible for this trial, participants must be 18 years or older, have NSCLC that is in stages II to IIIB, and not have certain gene mutations. They should also be scheduled to begin new immune therapy and have a good overall health score. Unfortunately, people with other active cancers, certain autoimmune diseases, or those who have had previous chemotherapy or radiotherapy are not able to participate. If someone joins the trial, they can expect to have their health closely monitored throughout the study, contributing to important research that might help future patients with lung cancer.

Gender

ALL

Eligibility criteria

• 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.