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NCT Number: NCT06711770

Effect of G-CSF on MDSC and Cancer Stem-cells Interactions 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Phenotype of MDSC and CSC

    Time frame: 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

  2. Functions of MDSC and CSC

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte DOMBLIDES

CONTACT

[email protected]

+33556795808

Nicolas LARMONIER

CONTACT

[email protected]

+33557579246

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: CIRCUIT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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