Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC (NCT07392073) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC
80 participantsStarted 2026-04
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 comp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From treatment initiation to first documented disease progression or death, assessed up to 24 months
Trial details
NCT IDNCT07392073
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine