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

ConditionsNon Small Cell Lung Cancer Immunotherapy Granulocyte Colony Stimulating Factor

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patient with a small cell lung carcinoma

Non-metastatic disease

Actionable mutation or genomic alteration in EGFR, ALK or ROS1

Corticosteroids > 10 mg/j

Trial design

Design model

Parallel

Treatments tested in this trial

Blood sample
Biological/Vaccine
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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Patients receiving G-CSFOther 1 intervention

Group B: Patients without G-CSFOther 1 intervention

Trial outcomes

Primary outcomes

Phenotype of MDSC and CSC

Expression of different MDSC markers corresponding to the rate of the different MDSC subpopulations

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

Functions of MDSC and CSC

Immunosuppressive and non immunosuppressive functions of the different populations of MDSC

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: