Study of Small Extracellular Vesicle miRNAs to Predict Treatment Success in Extensive-stage Small Cell Lung Cancer Using Immunotherapy Plus Chemotherapy

What this Trial Is About

Researchers are investigating the role of small extracellular vesicle sEV microRNAs miRNAs as predictive biomarkers for how well immunochemotherapy works in people with extensive-stage small cell lung cancer ES-SCLC, a very aggressive type of lung cancer. Since current treatments combining immune checkpoint inhibitors with chemotherapy do not have markers to predict which patients will benefit, this study aims to find miRNA patterns that differentiate patients who respond to treatment from those who do not. This research is taking place at Shanghai Chest Hospital and focuses on treatment-nave patients with ES-SCLC. The study involves collecting blood samples before patients start immunotherapy combined with chemotherapy to analyze the miRNA in serum sEVs. The research team will sequence these miRNAs and compare differences between responders and non-responders. They will categorize tumor responses as partial response significant tumor shrinkage, stable disease no significant change in tumor size, or progressive disease tumor growth or new lesions. This observational study tracks patients receiving the combination treatment of ECEP chemotherapy plus immune checkpoint inhibitors. Participants will be monitored over time with assessments including tumor response status every 6 to 8 weeks and measurement of baseline serum sEV miRNA levels before treatment begins. The study collects complete clinical sample and follow-up information to identify biomarkers that may help guide personalized treatment decisions for ES-SCLC. The trial is expected to continue until the end of 2026 and includes adults aged 45 to 80 years who are starting immunochemotherapy for the first time.

Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer