Lung CancerPNN-CPNCT06244355
Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer
An observational study of Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Extra blood tubes
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of metastatic stage lung cancer with mutation status, naïve treatment
- Diagnosis of COPD post-smoking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit
Paris, Île-de-France Region, 75014
Marie WISLEZ, Pr, +33 1 58 41 18 89, marie.wislez@aphp.fr
Marie WISLEZ, Pr
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Extra blood tubes
- Keywords
- Neutrophils, neutrophil subsets, Advanced lung cancer, biomarkers, PD-1 immunotherapy, Chronic inflammation, Phenotypic modulation, Spectral cytometry
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra blood tubesOther
Extra blood tubes
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer | Metastatic, with complete mutational status, without anterior treatment Receives: Other: Extra blood tubes | |
| Chronic obstructive pulmonary disease (COPD) | Diagnosis of post-smoking COPD (without diagnosis of CP) Receives: Other: Extra blood tubes | |
| Healthy volunteers | Healthy volunteers (based on biological and clinical data already available from the partner) Receives: Other: Extra blood tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 years
Secondary outcomes (9)
Demographic characteristics
Demographic characteristics : age, sex and smoking
Measured: Day 1
Performans status
Somatic characteristics
Measured: Day 1
Stage
Somatic characteristics
Measured: Day 1
Histologic type
Histologic characteristics
Measured: Day 1
Mutation status
Molecular characteristics
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Up to the end of participation, between month 3 and month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Feb 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie WISLEZ, Pr, Principal investigator, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244355
- Sponsor's protocol ID
- APHP220335
- Other IDs
- 2021-A01939-32
- Acronym
- PNN-CP
- Status last verified
- Mar 2026
- First submitted
- 27 Oct 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Phenotypic and Functional Characteristics of Circulating Neutrophil Subpopulations in Patients With Lung Cancer Undergoing Treatment
- ClinicalTrials.gov ID
- NCT06244355
- Acronym / sponsor ID
- PNN-CP / APHP220335
- Conditions
- Lung Cancer
- Keywords
- Neutrophils, neutrophil subsets, Advanced lung cancer, biomarkers, PD-1 immunotherapy, Chronic inflammation, Phenotypic modulation, Spectral cytometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung cancer | – | Other: Extra blood tubesMetastatic, with complete mutational status, without anterior treatment |
| Chronic obstructive pulmonary disease (COPD) | – | Other: Extra blood tubesDiagnosis of post-smoking COPD (without diagnosis of CP) |
| Healthy volunteers | – | Other: Extra blood tubesHealthy volunteers (based on biological and clinical data already available from the partner) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of metastatic stage lung cancer with mutation status, naïve treatment
- Diagnosis of COPD post-smoking
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extra blood tubesExtra blood tubes | Other | Chronic obstructive pulmonary disease (COPD), Healthy volunteers, Lung cancer |
Primary outcome
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.
9 secondary outcomes
Demographic characteristics
Time frame: Day 1
Performans status
Time frame: Day 1
Stage
Time frame: Day 1
Histologic type
Time frame: Day 1
Mutation status
Time frame: Day 1
Clinical assessment
Time frame: Up to the end of participation, between month 3 and month 4
irRECIST 1.1 response
Time frame: Up to the end of participation, between month 3 and month 4
Death
Time frame: Up to the end of participation, between month 3 and month 4
Mortality
Time frame: Up to the end of participation, between month 3 and month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie WISLEZ, Pr principal investigator
Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie WISLEZ, Pr (+33 1 58 41 18 89, marie.wislez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a subpopulation of circulating neutrophils (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.