Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)

Treatment groups

80 Participants
are divided into 1 treatment group

Locations

This trial has no locations