Immunodynamics-Guided Optimization of Individualized Immunochemotherapy in Advanced Driver-Negative NSCLC: A Randomized Trial

The goal of this clinical trial is to evaluate whether individualized sequencing of immunotherapy and chemotherapy based on immune dynamics can improve treatment outcomes in adults with advanced non-small cell lung cancer (NSCLC) without driver gene mutations. This study will also assess the safety and feasibility of different infusion strategies. The main questions it aims to answer are: Does optimizing the timing of PD-1 inhibitor infusion relative to chemotherapy improve the objective response rate (ORR)? Does individualized infusion sequencing enhance progression-free survival (PFS) compared to standard or fixed-delay administration? What safety concerns or immune-related adverse events occur with different infusion timing strategies? Researchers will compare three treatment strategies: Group A (Standard Concurrent Group): Immunotherapy and chemotherapy administered on the same day (D1). Group B (Fixed Delay Group): Chemotherapy on D1, followed by PD-1 inhibitor infusion on Day 3. Group C (Individualized Delay Group): Chemotherapy on D1, and PD-1 inhibitor infusion scheduled on D2-D6 based on daily immune monitoring. Participants will: Receive a PD-1 inhibitor (e.g., sintilimab, pembrolizumab, camrelizumab) combined with platinum-based chemotherapy. Attend clinic visits for regular immune monitoring, imaging assessments, and safety checks during each treatment cycle. Undergo blood tests to evaluate immune biomarkers (e.g., CD8⁺PD-1⁺ T cells, MDSC, Treg、IFN-γ、NLR、ALC、CRP) to guide individualized treatment decisions.

NCT Number	NCT07190027
Lead Sponsor	First Affiliated Hospital of Wenzhou Medical University
Conditions	Advanced Non-Small Cell Lung Cancer (NSCLC)
Enrollment	246 participants
Start Date	2025-11
Primary Completion	2025-11 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2025-09-24