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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer; Immunotherapy; Granulocyte Colony Stimulating Factor
• Intervention / Treatment: Biological: Blood sample

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte DOMBLIDES; Phone Number: +33556795808; Email: charlotte.domblides@chu-bordeaux.fr
• Study Contact Backup: Name: Nicolas LARMONIER; Phone Number: +33557579246; Email: nicolas.larmonier@u-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • CHU de Bordeaux, service d'Oncologie Médicale
    • Contact: Charlotte DOMBLIDES; Phone Number: +33556795808; Email: charlotte.domblides@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients receiving G-CSF	Biological: Blood sample; Four tubes of 7 mL collected at baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse
Other: Patients without G-CSF	Biological: Blood sample; Four tubes of 7 mL collected at baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Immunotherapy; Non-small cell lung cancer; Myeloid-Derived Suppressor Cells; Granulocyte-Colony Stimulating Factor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CHUBX 2023/54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No