Granulocyte Colony Stimulating Factor, Immunotherapy, Non Small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer, Immunotherapy, Myeloid-Derived Suppressor Cells, Granulocyte-Colony Stimulating Factor
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
Interventions
BIOLOGICALBlood 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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenotype of MDSC and CSC | 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 |
| Functions of MDSC and CSC | 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 |
Countries
France
Contacts
Primary ContactCharlotte DOMBLIDES
Backup ContactNicolas LARMONIER
Outcome results
None listed