Clinical trial · Observational
Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC
Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Squamous Cell Carcinoma | Lung Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage IIIB Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NSCLC Patients Receiving Chemoimmunotherapy
- description
- 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.
- interventionNames
- Diagnostic Test: Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From treatment initiation to first documented disease progression or death, assessed up to 24 months
- description
- 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).
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Study Termination Criteria: * Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy * Death or loss to follow-up \>6 months * Unacceptable grade 4 treatment-related toxicity * Investigator determination that continued participation poses health risk to patient * Study terminated by ethics committee for scientific or administrative reasons
References
Publications (0)
Data not yet available