Clinical trial NCT06711770: Effect of G-CSF on MDSC and Cancer Stem-cells Interactions in Non-small Cell Lung Cancers (CIRCUIT)
Official title: Characterization of the Effect of G-CSF on the Interactions Between MDSC and Cancer Stem-cells in Non-small Cell Lung Cancers (CIRCUIT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Phenotype of MDSC and CSC
timeFrame: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse
measure: Functions of MDSC and CSC
timeFrame: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, service d'Oncologie Médicale
Study officials:
References: