Non-Small Cell Lung CancerNCT07392073
Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC
An observational study of Non-Small Cell Lung Cancer and Lung Adenocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma
- What is being tested?
- Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Jun 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
About this study
Official title: Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer
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
Read more
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
Read the detailed description
Non-small cell lung cancer (NSCLC) accounts for the majority of lung cancer cases globally. While immune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy, have become standard first-line therapy for advanced NSCLC, only a subset of patients achieve clinical benefit. Current biomarkers including PD-L1 expression and tumor mutational burden (TMB) have limited predictive accuracy, creating an urgent need for more reliable biomarkers.
Tumor antigen-specific T cells (TASTs) are the actual effectors in ICI therapy, and successful ICI response depends on reactivation of these cells. However, detection of circulating tumor antigen-specific T cells (CTASTs) has been technically challenging due to their low frequency and heterogeneity in peripheral blood.
This study utilizes a novel Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT) developed by the research team. The technology employs Tumor Antigen-specific T cell Activating Nanoparticles (TATAN) loaded with whole tumor cell components to specifically activate and quantify effector TASTs (ETASTs) in peripheral blood.
Study Design:
This is a prospective, single-center, observational cohort study enrolling 80 patients with stage IIIB-IV NSCLC receiving standard PD-1 inhibitor plus platinum-based chemotherapy. Peripheral blood samples (5 mL) will be collected at two time points: baseline (T0, within 1 day before treatment initiation) and after completion of cycle 2 (T1, day 21 of cycle 2).
ETAST Detection Protocol:
- PBMC isolation from peripheral blood using Ficoll density gradient centrifugation
- Co-incubation of PBMCs with TATAN nanoparticles (50 μg/mL) for 48 hours at 37°C
- Flow cytometric quantification of activated ETASTs defined as CD3+CD8+IFN-γ+ and CD3+CD8+CD137+ double-positive cells
- Calculation of ΔETAST: [(ETASTs-T1 - ETASTs-T0) / ETASTs-T0] × 100%
Primary Endpoint:
Progression-free survival (PFS), defined as time from treatment initiation to first documented disease progression per RECIST 1.1 or death from any cause, assessed by independent radiology committee.
Secondary Endpoints:
- Comparison of predictive performance (ROC curve AUC) between ΔETASTs and traditional biomarkers (PD-L1 TPS, TMB) using DeLong test
- Objective response rate (ORR), overall survival (OS), disease control rate (DCR)
- Treatment-related adverse events graded per CTCAE 5.0
Statistical Analysis:
Cox proportional hazards regression will assess the association between ΔETASTs and PFS. Patients will be stratified by median ΔETAST value into high and low change groups for survival comparisons using Kaplan-Meier curves and log-rank tests. Sample size of 80 provides 80% power to detect HR=0.42 with α=0.05, accounting for 15% dropout rate.
The study aims to establish ΔETASTs as a superior biomarker for predicting chemoimmunotherapy efficacy in NSCLC, potentially enabling precision patient selection and improving treatment outcomes.
- Conditions
- Non-Small Cell Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer
- Being tested
- Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)
- Keywords
- Tumor Antigen-Specific T Cells, Effector T Cells, Circulating T Cells, Biomarkers, PD-1 Inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: From baseline to after completion of cycle 2 (approximately day 42)
Predictive Performance Comparison: ΔETASTs vs. Traditional Biomarkers
Measured: At 6 months and 12 months after treatment initiation
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria, assessed by independent radiology committee. Comparison between high vs. low ΔETAST groups.
Measured: Best overall response from treatment initiation through study completion, up to 24 months
Overall Survival (OS)
Time from first dose of chemoimmunotherapy to death from any cause. Patients alive at end of study will be censored at last known alive date.
Measured: From treatment initiation to death from any cause, assessed up to 24 months
Incidence of Treatment-Related Adverse Events
Incidence, type, and severity of adverse events related to chemoimmunotherapy, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Particular focus on immune-related adverse events (irAEs) including pneumonitis, hepatitis, colitis, myocarditis, and endocrinopathies. Safety of blood sampling procedures also monitored.
Measured: From treatment initiation through 30 days after last treatment dose, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibiao Zeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392073
- Sponsor's protocol ID
- 20251026103020786-2
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07392073
- Acronym / sponsor ID
- 20251026103020786-2
- Conditions
- Non-Small Cell Lung Cancer, Lung Adenocarcinoma, Lung Squamous Cell Carcinoma, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer
- Keywords
- Tumor Antigen-Specific T Cells, Effector T Cells, Circulating T Cells, Biomarkers, PD-1 Inhibitor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Non-small cell lung cancer (NSCLC) accounts for the majority of lung cancer cases globally. While immune checkpoint inhibitors (ICIs), particularly PD-1/PD-L1 inhibitors combined with platinum-based chemotherapy, have become standard first-line therapy for advanced NSCLC, only a subset of patients achieve clinical benefit. Current biomarkers including PD-L1 expression and tumor mutational burden (TMB) have limited predictive accuracy, creating an urgent need for more reliable biomarkers.
Tumor antigen-specific T cells (TASTs) are the actual effectors in ICI therapy, and successful ICI response depends on reactivation of these cells. However, detection of circulating tumor antigen-specific T cells (CTASTs) has been technically challenging due to their low frequency and heterogeneity in peripheral blood.
This study utilizes a novel Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT) developed by the research team. The technology employs Tumor Antigen-specific T cell Activating Nanoparticles (TATAN) loaded with whole tumor cell components to specifically activate and quantify effector TASTs (ETASTs) in peripheral blood.
Study Design:
This is a prospective, single-center, observational cohort study enrolling 80 patients with stage IIIB-IV NSCLC receiving standard PD-1 inhibitor plus platinum-based chemotherapy. Peripheral blood samples (5 mL) will be collected at two time points: baseline (T0, within 1 day before treatment initiation) and after completion of cycle 2 (T1, day 21 of cycle 2).
ETAST Detection Protocol:
- PBMC isolation from peripheral blood using Ficoll density gradient centrifugation
- Co-incubation of PBMCs with TATAN nanoparticles (50 μg/mL) for 48 hours at 37°C
- Flow cytometric quantification of activated ETASTs defined as CD3+CD8+IFN-γ+ and CD3+CD8+CD137+ double-positive cells
- Calculation of ΔETAST: [(ETASTs-T1 - ETASTs-T0) / ETASTs-T0] × 100%
Primary Endpoint:
Progression-free survival (PFS), defined as time from treatment initiation to first documented disease progression per RECIST 1.1 or death from any cause, assessed by independent radiology committee.
Secondary Endpoints:
- Comparison of predictive performance (ROC curve AUC) between ΔETASTs and traditional biomarkers (PD-L1 TPS, TMB) using DeLong test
- Objective response rate (ORR), overall survival (OS), disease control rate (DCR)
- Treatment-related adverse events graded per CTCAE 5.0
Statistical Analysis:
Cox proportional hazards regression will assess the association between ΔETASTs and PFS. Patients will be stratified by median ΔETAST value into high and low change groups for survival comparisons using Kaplan-Meier curves and log-rank tests. Sample size of 80 provides 80% power to detect HR=0.42 with α=0.05, accounting for 15% dropout rate.
The study aims to establish ΔETASTs as a superior biomarker for predicting chemoimmunotherapy efficacy in NSCLC, potentially enabling precision patient selection and improving treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC Patients Receiving Chemoimmunotherapy | – | Diagnostic Test: Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating Tumor-Specific T Cell Nanodetection Technology (CTT-NanoDT)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%. | Diagnostic test | NSCLC Patients Receiving Chemoimmunotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From treatment initiation to first documented disease progression or death, assessed up to 24 months
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).
5 secondary outcomes
Change in Effector Tumor Antigen-Specific T Cells (ΔETASTs)
Time frame: From baseline to after completion of cycle 2 (approximately day 42)
Predictive Performance Comparison: ΔETASTs vs. Traditional Biomarkers
Time frame: At 6 months and 12 months after treatment initiation
Objective Response Rate (ORR)
Time frame: Best overall response from treatment initiation through study completion, up to 24 months
Overall Survival (OS)
Time frame: From treatment initiation to death from any cause, assessed up to 24 months
Incidence of Treatment-Related Adverse Events
Time frame: From treatment initiation through 30 days after last treatment dose, up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer and Lung Adenocarcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From treatment initiation to first documented disease progression or death, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.