An observational study in Non-small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 150 is close to the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with advanced non-small cell lung cancer (stage IIIA-IVB) anticipate to receive primary/first-line immunotherapy
Exclusion Criteria:
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.
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.
Time frame: 4 weeks
progression-free survival (PFS)
progression-free survival (PFS) defined as time from surgery until disease progression or death from any cause
Time frame: 1 year
overall survival (OS)
Overall survival (OS) was defined as the time from surgery until death from any cause
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Shanghai Pulmonary Hospital, Shanghai, China