Non-small Cell Lung CancerNCT06054152
CX3CR1+T Cell Predict Immunotherapy Efficacy
An observational study of Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
Trial summary
This study aimed to evaluate the correlation between the proportion of flow-sorted CX3CR1+T cells in peripheral blood and the CX3CR1+T-specific gene signature and the efficacy of immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- PD-1 inhibitor based immunotherapy
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 10 Apr 2023to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with advanced non-small cell lung cancer (stage IIIA-IVB) anticipate to receive primary/first-line immunotherapy
Who may be able to join
- At least 18 years old;
- Diagnosed as Non-small cell lung cancer by biopsy before treatment;
- Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs;
- Lesion imaging can be measured and evaluated by RECIST1.1 standard;
- Life expectancy exceeds 3 months;
- ECOG score 0-2;
- The newly IO treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial;
- Sign informed consent and be willing to provide 5ml of peripheral blood for research
Who cannot join
- Genetic test showed EGFR and ALK mutations;
- Patients with other co-morbidities that may affect their follow-up and short-term survival;
- Patients with any history of antitumor therapy;
- Patients with a history of other systemic tumors;
- The ineligible participants assessed by the researchers
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan cancer hospital
Changsha, Hunan
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
About this study
Official title: Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood
This study aimed to evaluate the correlation between the proportion of flow-sorted CX3CR1+T cells in peripheral blood and the CX3CR1+T-specific gene signature and the efficacy of immunotherapy.
Read the detailed description
The status and abundance of T cells vary across tumor microenvironments (TMEs) may fundamentally influence response to immunotherapy in non-small cell lung cancer. CX3CR1+ CD8+ T cells showed high migration in and were enriched in the blood, whose amplification is strongly associated with response to anti-PD-1 therapy and better survival. However, the prediction performance of CX3CR1+ T features and characteristics has not been fully validated. This study intends to conduct a clinical trial based on CX3CR1+ CD8+T Cell in peripheral blood to verify the association of proportion and specific transcriptome signature of CX3CR1+T Cell in immunotherapy efficacy prediction. With the help of RECIST 1.1 criteria, the investigators evaluate the clinical response after prescribed cycles of treatment to explore the correlation between peripheral blood markers and immunotherapy efficacy. To develop a low cost, robust and accurate prototype prediction model for NSCLC patients who take anti-PD-1 drugs is investigators final translational purpose.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- PD-1 inhibitor based immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitor based immunotherapyDrug
Patients received at least 4 cycles of PD-1 inhibitor-based immune monotherapy or chemoimmunotherapy. PD-1 drug selection should be limited in 4 types of PD-1 inhibitor approved by China FDA and launched in China and Opdivo or Keytruda.
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate（ORR）
Imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing 4 cycles of immunotherapy. best overall response (BoR) was evaluated in participants achieving complete and partial response.
Measured: 4 weeks
Secondary outcomes (2)
progression-free survival (PFS)
progression-free survival (PFS) defined as time from surgery until disease progression or death from any cause
Measured: 1 year
overall survival (OS)
Overall survival (OS) was defined as the time from surgery until death from any cause
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start10 Apr 2023
- Primary completion1 Jan 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Chang Chen, MD, Ph.D., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaDeping Zhao, MD, Ph.D., Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054152
- Sponsor's protocol ID
- CTPI
- Status last verified
- Jun 2025
- First submitted
- 19 Sep 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng L, Qin S, Si W, Wang A, Xing B, Gao R, Ren X, Wang L, Wu X, Zhang J, Wu N, Zhang N, Zheng H, Ouyang H, Chen K, Bu Z, Hu X, Ji J, Zhang Z. Pan-cancer single-cell landscape of tumor-infiltrating T cells. Science. 2021 Dec 17;374(6574):abe6474. doi: 10.1126/science.abe6474. Epub 2021 Dec 17.
PubMed 34914499Yamauchi T, Hoki T, Oba T, Jain V, Chen H, Attwood K, Battaglia S, George S, Chatta G, Puzanov I, Morrison C, Odunsi K, Segal BH, Dy GK, Ernstoff MS, Ito F. T-cell CX3CR1 expression as a dynamic blood-based biomarker of response to immune checkpoint inhibitors. Nat Commun. 2021 Mar 3;12(1):1402. doi: 10.1038/s41467-021-21619-0.
PubMed 33658501Dong Y, Xu X, Si H, Li Y, Yang D, Chen J, Wang Y, Zhang HM, Yang L, Xie H, Yang M, Shi B, Zhao D, Hu X, Wen J, Xu L, Wu J, Chen C. A machine learning model integrating circulating Temra cell transcriptional profiles to predict immunotherapy efficacy. Med. 2026 Apr 10;7(4):101027. doi: 10.1016/j.medj.2026.101027. Epub 2026 Feb 25.
PubMed 41747737
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood
- ClinicalTrials.gov ID
- NCT06054152
- Acronym / sponsor ID
- CTPI
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 26 Sep 2023 (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.
This study aimed to evaluate the correlation between the proportion of flow-sorted CX3CR1+T cells in peripheral blood and the CX3CR1+T-specific gene signature and the efficacy of immunotherapy.
Detailed description
The status and abundance of T cells vary across tumor microenvironments (TMEs) may fundamentally influence response to immunotherapy in non-small cell lung cancer. CX3CR1+ CD8+ T cells showed high migration in and were enriched in the blood, whose amplification is strongly associated with response to anti-PD-1 therapy and better survival. However, the prediction performance of CX3CR1+ T features and characteristics has not been fully validated. This study intends to conduct a clinical trial based on CX3CR1+ CD8+T Cell in peripheral blood to verify the association of proportion and specific transcriptome signature of CX3CR1+T Cell in immunotherapy efficacy prediction. With the help of RECIST 1.1 criteria, the investigators evaluate the clinical response after prescribed cycles of treatment to explore the correlation between peripheral blood markers and immunotherapy efficacy. To develop a low cost, robust and accurate prototype prediction model for NSCLC patients who take anti-PD-1 drugs is investigators final translational purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced non-small cell lung cancer (stage IIIA-IVB) anticipate to receive primary/first-line immunotherapy
Key inclusion criteria (8 listed)
- At least 18 years old;
- Diagnosed as Non-small cell lung cancer by biopsy before treatment;
- Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs;
- Lesion imaging can be measured and evaluated by RECIST1.1 standard;
- Life expectancy exceeds 3 months;
Key exclusion criteria (5 listed)
- Genetic test showed EGFR and ALK mutations;
- Patients with other co-morbidities that may affect their follow-up and short-term survival;
- Patients with any history of antitumor therapy;
- Patients with a history of other systemic tumors;
- The ineligible participants assessed by the researchers
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 |
|---|---|---|
| PD-1 inhibitor based immunotherapyPatients received at least 4 cycles of PD-1 inhibitor-based immune monotherapy or chemoimmunotherapy. PD-1 drug selection should be limited in 4 types of PD-1 inhibitor approved by China FDA and launched in China and Opdivo or Keytruda. | Drug | – |
Primary outcome
objective response rate（ORR）
Time frame: 4 weeks
Imaging findings of CR, PR, and stable disease (SD) in all subjects evaluated according to RECIST V1.1 after completing 4 cycles of immunotherapy. best overall response (BoR) was evaluated in participants achieving complete and partial response.
2 secondary outcomes
progression-free survival (PFS)
Time frame: 1 year
overall survival (OS)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 34914499Zheng L, Qin S, Si W, Wang A, Xing B, Gao R, Ren X, Wang L, Wu X, Zhang J, Wu N, Zhang N, Zheng H, Ouyang H, Chen K, Bu Z, Hu X, Ji J, Zhang Z. Pan-cancer single-cell landscape of tumor-infiltrating T cells. Science. 2021 Dec 17;374(6574):abe6474. doi: 10.1126/science.abe6474. Epub 2021 Dec 17.
- Background: PubMed 33658501Yamauchi T, Hoki T, Oba T, Jain V, Chen H, Attwood K, Battaglia S, George S, Chatta G, Puzanov I, Morrison C, Odunsi K, Segal BH, Dy GK, Ernstoff MS, Ito F. T-cell CX3CR1 expression as a dynamic blood-based biomarker of response to immune checkpoint inhibitors. Nat Commun. 2021 Mar 3;12(1):1402. doi: 10.1038/s41467-021-21619-0.
- Derived from this study: PubMed 41747737Dong Y, Xu X, Si H, Li Y, Yang D, Chen J, Wang Y, Zhang HM, Yang L, Xie H, Yang M, Shi B, Zhao D, Hu X, Wen J, Xu L, Wu J, Chen C. A machine learning model integrating circulating Temra cell transcriptional profiles to predict immunotherapy efficacy. Med. 2026 Apr 10;7(4):101027. doi: 10.1016/j.medj.2026.101027. Epub 2026 Feb 25.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chang Chen, MD, Ph.D. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Deping Zhao, MD, Ph.D. principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
objective response rate（ORR） (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054152, which also lists 3 linked publications.
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 25 Jun 2025.