The goal of this observational study is to explore whether changes in peripheral blood effector tumor antigen-specific T cells (ETASTs) can predict treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) receiving chemoimmunotherapy. The study aims to:
* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival * Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB) * Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy
Participants will:
* Provide peripheral blood samples at baseline and after cycle 2 of treatment * Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles * Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria * Be followed for progression-free survival and overall survival up to 24 months
Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)
Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed/carboplatin)
Age 18-80 years
ECOG performance status 0-1
No measurable disease per RECIST 1.1 criteria
Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome)
Active untreated central nervous system metastases or leptomeningeal disease
Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment
Adults aged 18-80 years with histologically confirmed stage IIIB-IV non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) with adequate performance status (ECOG 0-1) and organ function, receiving standard PD-1 inhibitor plus platinum-based chemotherapy as first-line or subsequent-line systemic treatment.
Cohort
Prospective
Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)
Diagnostic testNovel detection method for quantifying effector tumor antigen-specific T cells (ETASTs) in peripheral blood. PBMCs isolated from 5 mL peripheral blood are co-incubated with TATAN nanoparticles (whole tumor cell antigen-loaded nanoparticles, 50 μg/mL) for 48 hours. Activated ETASTs are identified and quantified by multi-color flow cytometry as CD3+CD8+IFN-γ+ and CD3+CD8+CD137+ double-positive cells. Quality control requires coefficient of variation (CV) \< 5%.
Progression-Free Survival (PFS)
Time from first dose of chemoimmunotherapy to first documented disease progression per RECIST 1.1 criteria (assessed by independent radiology committee) or death from any cause, whichever occurs first. Tumor assessments performed every 2 treatment cycles (approximately every 6 weeks).
Change in Effector Tumor Antigen-Specific T Cells (ΔETASTs)
Predictive Performance Comparison: ΔETASTs vs. Traditional Biomarkers
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by independent radiology committee. Comparison between high vs. low ΔETAST groups.
Overall Survival (OS)
Time from first dose of chemoimmunotherapy to death from any cause. Patients alive at end of study will be censored at last known alive date.
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