Lung Cancer
Conditions
Keywords
Neutrophils, neutrophil subsets, Advanced lung cancer, biomarkers, PD-1 immunotherapy, Chronic inflammation, Phenotypic modulation, Spectral cytometry
Brief summary
The objective is to study the phenotypic, functional and metabolomic characteristics of neutrophils circulating subpopulations in lung cancer patients, and to compare them to a control group of healthy volunteers. A blood sample will be taken before the first treatment session for the lung cancer patient and a second blood sample will be taken during the first evaluation visit. The investigators hypothesize that there may be different circulating neutrophil subpopulations in patients with metastatic non-small cell lung cancer (NSCLC) involved in tumor progression and resistance to immunotherapy.
Detailed description
Immune checkpoint inhibitors (ICI) have been shown to be effective in metastatic lung cancer. Unfortunately, 80% of patients do not respond and show rapid disease progression. Identifying predictive biomarkers of response is essential for early adaptation of management. Circulating lymphocytes and neutrophils represent a biomarker (NLR), predictive of immunotherapy response, in particular via the measurement of the neutrophils /lymphocyte ratio. Some preclinical work suggests a role for circulating neutrophil subpopulations like MDSC (myeloid derived suppressor cells) in ICI resistance. Certain circulating neutrophil subpopulations are thought to promote tumor progression, angiogenesis and metastasis with immunosuppressive activity. Identifying these pro-tumor subpopulations could predict the response to ICI and could be a potential therapeutic target. Our goal is to characterize the circulating neutrophil subpopulations of lung cancer patients and correlate these characteristics with response and survival phenotypically and functionally.
Interventions
OTHERExtra blood tubes
Extra blood tubes
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
common to lung cancer and COPD patients : * Age ≥ 18 years, * male or female, * affiliated with a Health Insurance, Inclusion Criteria for lung cancer patients : \- Diagnosis of metastatic stage lung cancer with mutation status, naïve treatment Inclusion Criteria for COPD patients : \- Diagnosis of COPD post-smoking
Exclusion criteria
* Tuberculosis or other acute or chronic bacterial infections * Chronic progressive viral infections (Hepatitis B and C, HIV) * Previous or ongoing chemotherapy * Impossibility of giving the subject informed information. * Opposition to the research. * Participation in another research study with an exclusion period still in progress at pre-inclusion (possible inclusion in an observational study) * Vulnerable individual (pregnant, parturient or breastfeeding woman), persons under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision) * Patients benefiting from the AME
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of a subpopulation of circulating neutrophils | Through study completion, an average of 3 years | Presence of a subpopulation of circulating neutrophils in patients with lung cancer (absent in healthy volunteers and COPD patients) with phenotypic CD45+, CD15+, CD16+, CD62L-, LOX1+ and functional immunosuppressive characteristics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographic characteristics | Day 1 | Demographic characteristics : age, sex and smoking |
| Performans status | Day 1 | Somatic characteristics |
| Stage | Day 1 | Somatic characteristics |
| Histologic type | Day 1 | Histologic characteristics |
| Mutation status | Day 1 | Molecular characteristics |
| Clinical assessment | Up to the end of participation, between month 3 and month 4 | Progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) |
| irRECIST 1.1 response | Up to the end of participation, between month 3 and month 4 | CT scan to evaluate progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) |
| Death | Up to the end of participation, between month 3 and month 4 | Progression free survival (defined as the time between the start of treatment and the date of first observation of clinical or CT progression (irRECIST1.1 criterion) or death) |
| Mortality | Up to the end of participation, between month 3 and month 4 | Overall survival (defined as the time from treatment diagnosis to the date of death). |
Countries
France
Contacts
CONTACTMarie WISLEZ, Pr
CONTACTMarie BENHAMMANI-GODARD
PRINCIPAL_INVESTIGATORMarie WISLEZ, Pr
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
Outcome results
None listed