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

Lung Cancer Clinical Trial

— PNN-CP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244355
• Other study ID #: APHP220335
• Secondary ID: 2021-A01939-32
• Status: Recruiting
• Start date: February 12, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie WISLEZ, Pr
• Phone: +33 1 58 41 18 89
• Email: marie.wislez[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Extra blood tubes
Extra blood tubes

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic characteristics	Demographic characteristics : age, sex and smoking	Day 1
Secondary	Performans status	Somatic characteristics	Day 1
Secondary	Stage	Somatic characteristics	Day 1
Secondary	Histologic type	Histologic characteristics	Day 1
Secondary	Mutation status	Molecular characteristics	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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