CX3CR1+T Cell Predict Immunotherapy Efficacy

Non-small Cell Lung Cancer Clinical Trial

Official title:

Prediction of Immunotherapy Efficacy Based on Transcriptome of CX3CR1+T Cell in Peripheral Blood

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06054152
• Other study ID #: CTPI
• Status: Active, not recruiting
• Start date: April 10, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years old;

2. Diagnosed as Non-small cell lung cancer by biopsy before treatment;

3. Prepare to receive PD(L)1 inhibitor monotherapy or combined chemotherapy and antivascular drugs;

4. Lesion imaging can be measured and evaluated by RECIST1.1 standard;

5. Life expectancy exceeds 3 months;

6. ECOG score 0-2;

7. The newly IO treated patients did not receive immunotherapy, chemoradiotherapy before participate in the trial;

8. Sign informed consent and be willing to provide 5ml of peripheral blood for research

Exclusion Criteria:

1. Genetic test showed EGFR and ALK mutations;

2. Patients with other co-morbidities that may affect their follow-up and short-term survival;

3. Patients with any history of antitumor therapy;

4. Patients with a history of other systemic tumors;

5. The ineligible participants assessed by the researchers

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• PD-1 inhibitor based immunotherapy
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.

Locations

Country	Name	City	State
China	Hunan cancer hospital	Changsha	Hunan
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Yamauchi 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival (PFS)	progression-free survival (PFS) defined as time from surgery until disease progression or death from any cause	1 year
Secondary	overall survival (OS)	Overall survival (OS) was defined as the time from surgery until death from any cause	1 year

External Links

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