Effect of G-CSF on MDSC and Cancer Stem-cells Interactions in Non-small Cell Lung Cancers (CIRCUIT)

Not Applicable

Not yet recruiting

• Conditions: Non Small Cell Lung Cancer; Immunotherapy; Granulocyte Colony Stimulating Factor
• Interventions: Biological: Blood sample

• Registration Number: NCT06711770
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to immunologic (myeloid immunosuppressive cells) and non-immunologic (cancer stem- cells (CSC)) mechanisms. CSC are able to circulate within blood, protected from destruction by immunosuppressive cells such as MDSC. Some factors such as G-CSF, administered to lower febrile neutropenia, should modulate properties of MDSC and CSC, but data are contradictory, and literature remain poor regarding its effects on the interactions between MDSC and CSC in blood clusters. Indeed, this project aims at better characterizing the effect of G-CSF on these interactions and on their functions in NSCLC patients receiving G-CSF.

Detailed Description

MDSC, CSC and the clusters in blood from NSCLC patients will be assessed to evaluate the impact of G-CSF on their phenotype and functions. Samples from 2 groups of NSCLC patients receiving chemotherapy and immunotherapy will be used: 15 receiving concomitant G-CSF, and 15 not receiving concomitant G-CSF

Study Timeline

• Study First Submitted: 2024-10-09
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study Start: 2024-12
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients (male or female) aged ≥ 18 years
• Histological or cytological proven lung adenocarcinoma, metastatic or locally advanced not accessible to local therapy
• Receiving chemotherapy and immunotherapy as first-line treatment
• Signed written informed consent (no later than the day of inclusion, and before the blood sample collection)
• Patient affiliated or beneficiary to a health security system;

Exclusion Criteria

• Patient with a small cell lung carcinoma
• Non-metastatic disease
• Actionable mutation or genomic alteration in EGFR, ALK or ROS1
• Corticosteroids > 10 mg/j
• Autoimmune disease
• Active and uncontrolled HIV infection
• Concomitant cancer
• Pregnancy or lactating women
• Psychiatric or medical conditions that prohibit the understanding and rendering of informed consent
• Patient under a legal protection measure
• Patient with a deprived liberty condition
• Patient incapable of giving signed informed consent
• Patient within the exclusion period for another clinical trial, or participating to another interventional trial within 30 days before the beginning of this project

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving G-CSF	Blood sample	-
Patients without G-CSF	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Phenotype of MDSC and CSC	At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse	Expression of different MDSC markers corresponding to the rate of the different MDSC subpopulations
Functions of MDSC and CSC	At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse	Immunosuppressive and non immunosuppressive functions of the different populations of MDSC

Trial Locations

Locations (1)

CHU de Bordeaux, service d'Oncologie Médicale; 🇫🇷 Bordeaux, France