Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer (PNN-CP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Extra blood tubes

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marie BENHAMMANI-GODARD; Phone Number: +33 1 58411190; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Marie WISLEZ, Pr; Phone Number: +33 1 58 41 18 89; Email: marie.wislez@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75014
      • Recruiting
      • Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit
      • Principal Investigator: Marie WISLEZ, Pr
      • Contact: Marie WISLEZ, Pr; Phone Number: +33 1 58 41 18 89; Email: marie.wislez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lung cancer; Metastatic, with complete mutational status, without anterior treatment	Other: Extra blood tubes; Extra blood tubes
Chronic obstructive pulmonary disease (COPD); Diagnosis of post-smoking COPD (without diagnosis of CP)	Other: Extra blood tubes; Extra blood tubes
Healthy volunteers; Healthy volunteers (based on biological and clinical data already available from the partner)	Other: Extra blood tubes; Extra blood tubes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of a subpopulation of circulating neutrophils	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.	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	Demographic characteristics : age, sex and smoking	Day 1
Performans status	Somatic characteristics	Day 1
Stage	Somatic characteristics	Day 1
Histologic type	Histologic characteristics	Day 1
Mutation status	Molecular characteristics	Day 1
Clinical assessment	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)	Up to the end of participation, between month 3 and month 4
irRECIST 1.1 response	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)	Up to the end of participation, between month 3 and month 4
Death	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)	Up to the end of participation, between month 3 and month 4
Mortality	Overall survival (defined as the time from treatment diagnosis to the date of death).	Up to the end of participation, between month 3 and month 4

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Marie WISLEZ, Pr, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; Chronic inflammation; Neutrophils; Advanced lung cancer; neutrophil subsets; PD-1 immunotherapy; Phenotypic modulation; Spectral cytometry
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: APHP220335; 2021-A01939-32 (Other Identifier: France : ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No