Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06244355
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-06
• Study Start: 2024-02-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Stage	Day 1	Somatic characteristics
Mutation status	Day 1	Molecular characteristics
Performans status	Day 1	Somatic 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)
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).
Histologic type	Day 1	Histologic characteristics
Demographic characteristics	Day 1	Demographic characteristics : age, sex and smoking
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)

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit; 🇫🇷 Paris, Ile De France, France