NCT06054152

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

1.7 years

First QC Date

September 19, 2023

Last Update Submit

June 19, 2025

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (2)

  • progression-free survival (PFS)

    1 year

  • overall survival (OS)

    1 year

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with advanced non-small cell lung cancer (stage IIIA-IVB) anticipate to receive primary/first-line immunotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hunan cancer hospital

Changsha, Hunan, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (2)

  • 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.

    PMID: 34914499BACKGROUND

  • Williams HN, Kelley J, Folineo D, Williams GC, Hawley CL, Sibiski J. Assessing microbial contamination in clean water dental units and compliance with disinfection protocol. J Am Dent Assoc. 1994 Sep;125(9):1205-11. doi: 10.14219/jada.archive.1994.0164.

    PMID: 7930182BACKGROUND

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Chang Chen, MD, Ph.D.

    Shanghai Pulmonary Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

  • Deping Zhao, MD, Ph.D.

    Shanghai Pulmonary Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician, Secretary of the Party Committee

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

April 10, 2023

Primary Completion

January 1, 2025

Study Completion

June 20, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)