Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC

NCT07392073 | Not Yet Recruiting

• 1 other identifier: 20251026103020786-2
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lung Squamous Cell Carcinoma; Stage IIIB Non-Small Cell Lung Cancer; Stage IV Non-Small Cell Lung Cancer; Advanced Non-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Lung Adenocarcinoma

Keywords

Tumor Antigen-Specific T Cells; Effector T Cells; Circulating T Cells; Biomarkers; PD-1 Inhibitor

Outcome Measures

Primary Outcomes (1)

• 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).

  From treatment initiation to first documented disease progression or death, assessed up to 24 months

Secondary Outcomes (5)

• Change in Effector Tumor Antigen-Specific T Cells (ΔETASTs)

  From baseline to after completion of cycle 2 (approximately day 42)

• Predictive Performance Comparison: ΔETASTs vs. Traditional Biomarkers

  At 6 months and 12 months after treatment initiation

• Objective Response Rate (ORR)

  Best overall response from treatment initiation through study completion, up to 24 months

• Overall Survival (OS)

  From treatment initiation to death from any cause, assessed up to 24 months

• Incidence of Treatment-Related Adverse Events

  From treatment initiation through 30 days after last treatment dose, up to approximately 24 months

Study Arms (1)

NSCLC Patients Receiving Chemoimmunotherapy

Patients with stage IIIB-IV non-small cell lung cancer receiving standard PD-1 inhibitor (such as pembrolizumab) combined with platinum-based chemotherapy (such as pemetrexed/carboplatin or paclitaxel/carboplatin regimen). Peripheral blood samples collected at baseline and after cycle 2 for ETAST quantification using CTT-NanoDT technology.

Diagnostic Test: Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)

Interventions

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

Novel 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%.

NSCLC Patients Receiving Chemoimmunotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Expected survival ≥12 weeks
• Adequate bone marrow function: ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L
• Adequate hepatorenal function: Cr ≤1.5×ULN, ALT/AST ≤2.5×ULN
• At least one measurable lesion per RECIST 1.1 criteria
• Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up

You may not qualify if:

• 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
• Chronic use of immunosuppressive agents (e.g., corticosteroids \>10 mg/day prednisone equivalent)
• Coagulation disorders (INR \>1.5 or APTT \>1.5×ULN) or ongoing anticoagulation therapy
• Poor vascular access precluding serial venipuncture (\>5 mL per draw)
• Active hepatitis B (HBV DNA \>2000 IU/mL), hepatitis C, or HIV infection
• Uncontrolled bacterial or fungal infection requiring systemic treatment
• Pregnancy or lactation
• Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance
• Withdrawal Criteria:
• Participant voluntary withdrawal with signed withdrawal statement
• Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)
• Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-01