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

Summary

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.

Timeline

Start

2025-11

Primary completion

2025-11

Completion

2028-11

Drugs

Indications