NCT07392073Not yet recruiting
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 · Last updated 6 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2028
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Lung cancer
- NCT number
- NCT07392073
What you commit to
- Study type: Observational
- Planned participants: 80
- From Apr 2026 to the primary completion date, Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment
- Chronic use of immunosuppressive agents (e.g., corticosteroids \>10 mg/day prednisone equivalent)
- Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor
- Study Termination Criteria:
Other illness
- 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
- Active hepatitis B (HBV DNA \>2000 IU/mL), hepatitis C, or HIV infection
- Uncontrolled bacterial or fungal infection requiring systemic treatment
- Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance
- Withdrawal Criteria:
- Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)
- Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy
Lab values
- Coagulation disorders (INR \>1.5 or APTT \>1.5×ULN) or ongoing anticoagulation therapy
Other
- Poor vascular access precluding serial venipuncture (\>5 mL per draw)
- Pregnancy or lactation
- Participant voluntary withdrawal with signed withdrawal statement
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.