Clinical trial NCT06244355: Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer
Official title: Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer Undergoing Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Neutrophils
neutrophil subsets
Advanced lung cancer
biomarkers
PD-1 immunotherapy
Chronic inflammation
Phenotypic modulation
Spectral cytometry
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic lung cancer, without anterior treatment. Inclusion during a consultation or hospitalization by a pneumologist or oncologist in the thoracic oncology unit during care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of a subpopulation of circulating neutrophils
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Demographic characteristics
timeFrame: Day 1
measure: Performans status
timeFrame: Day 1
measure: Stage
timeFrame: Day 1
measure: Histologic type
timeFrame: Day 1
measure: Mutation status
timeFrame: Day 1
measure: Clinical assessment
timeFrame: Up to the end of participation, between month 3 and month 4
measure: irRECIST 1.1 response
timeFrame: Up to the end of participation, between month 3 and month 4
measure: Death
timeFrame: Up to the end of participation, between month 3 and month 4
measure: Mortality
timeFrame: Up to the end of participation, between month 3 and month 4
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit
state: Ile De France
Study officials:
affiliation: Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Marie WISLEZ, Pr
role: PRINCIPAL_INVESTIGATOR
References: