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NCT Number: NCT06244355

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit

Paris, Île-de-France Region, 75014, France

Location status: Recruiting

Location contact

Marie WISLEZ, Pr

CONTACT

[email protected]

+33 1 58 41 18 89

Marie WISLEZ, Pr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra blood tubes

Other

Extra blood tubes

Primary outcomes

  1. Presence of a subpopulation of circulating neutrophils

    Time frame: 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 outcomes

  1. Demographic characteristics

    Time frame: Day 1

    Demographic characteristics : age, sex and smoking

  2. Performans status

    Time frame: Day 1

    Somatic characteristics

  3. Stage

    Time frame: Day 1

    Somatic characteristics

  4. Histologic type

    Time frame: Day 1

    Histologic characteristics

  5. Mutation status

    Time frame: Day 1

    Molecular characteristics

  6. Clinical assessment

    Time frame: 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)

  7. irRECIST 1.1 response

    Time frame: 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)

  8. Death

    Time frame: 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)

  9. Mortality

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

+33 1 58411190

Marie WISLEZ, Pr

CONTACT

[email protected]

+33 1 58 41 18 89

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: PNN-CP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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