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.
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