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

NCT06711770 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/54
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; Immunotherapy; Granulocyte Colony Stimulating Factor

Keywords

Non-small cell lung cancer; Immunotherapy; Myeloid-Derived Suppressor Cells; Granulocyte-Colony Stimulating Factor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Patients receiving G-CSF

OTHER

Biological: Blood sample

Patients without G-CSF

OTHER

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

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

Patients receiving G-CSF; Patients without G-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient affiliated or beneficiary to a health security system;

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, service d'Oncologie Médicale

Bordeaux, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Charlotte DOMBLIDES

CONTACT

+33556795808; charlotte.domblides@chu-bordeaux.fr

Nicolas LARMONIER

CONTACT

+33557579246; nicolas.larmonier@u-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)