Non-small Cell Lung CancerIMMUNOLUNGNCT07608835
IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy
A study testing prospective collection of blood and tumor samples in people with Non-small Cell Lung Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Immunotherapy has helped improve the prognosis of metastatic lung cancer. However, only about 40% of patients respond to conventional immunotherapy with anti-PD(L)-1 agents. This research aims to identify biomarkers of response to immunotherapy at the tumor level and to characterize new therapeutic targets Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- prospective collection of blood and tumor samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2026to 12 May 2033
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged 18 years or older, male or female.
- Willing to participate in the study and having signed a written informed consent form.
- Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.
- Affiliated with a social security system or benefiting from such a system.
Who cannot join
- Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.
- Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.
- History of solid organ transplantation or hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
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
Rochigneux
Marseille, Institut Paoli Calmettes, 13009
allison ARTHUR, 0491223448
About this study
Official title: IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069
Immunotherapy has helped improve the prognosis of metastatic lung cancer. However, only about 40% of patients respond to conventional immunotherapy with anti-PD(L)-1 agents. This research aims to identify biomarkers of response to immunotherapy at the tumor level and to characterize new therapeutic targets
Read the detailed description
The primary objective of this clinical study is to understand how certain blood markers can predict the effectiveness of immunotherapy treatments for patients with advanced-stage lung cancer.
This is a multicenter study with a total duration of 7 years.
In addition, the study will address several secondary objectives:
Compare biological markers present in the blood with those found in lung cancer tumors.
Investigate differences between tumor markers at early versus advanced stages of the disease.
Identify new markers that may predict the effectiveness of immunotherapy treatments.
Explore a specific mechanism (called HVEM/BTLA) involved in lung cancer, whether at an early or advanced stage.
To achieve the study objectives, 200 patients are expected to be enrolled, and the study will be conducted across two institutions.
In this study, the following biological samples will be collected: blood and tissue samples at the time of inclusion, and again at disease progression if it occurs during follow-up.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- prospective collection of blood and tumor samples
- Keywords
- lung cancer, immunotherapie, progression free survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective collection of blood and tumor samplesProcedure or surgery
The procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples.
The protocol-mandated tumor sampling at progression will be performed in the following two situations:
- If, as part of routine clinical care, a biopsy is planned, an additional tumor sample for the study will be collected.
- If the patient has consented to undergoing a protocol-specific tumor biopsy at the time of progression
| Study group | Role | What they receive |
|---|---|---|
| patients with localized NSCLC | Other | This project is based on the prospective collection of blood and tumor samples from NSCLC patients, along with the corresponding clinical data.One hundred patients with localized NSCLC will be enrolled at each participating center; these are patients with resectable NSCLC treated by surgery. Receives: Procedure: prospective collection of blood and tumor samples |
| patients with advanced NSCLC | Other | One hundred patients with advanced NSCLC will be enrolled at the center whose Principal Investigator is the scientific coordinator. These are patients with unresectable NSCLC who are not eligible for surgery and whose initial treatment consists of medical therapy (chemotherapy and/or immunotherapy). The samples are obtained using non-invasive techniques (mostly CT-guided biopsy and, less frequently, bronchoscopic or esophageal endoscopic biopsy). Receives: Procedure: prospective collection of blood and tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC
Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.
Measured: until the patient's death"or until the end of the patient follow-up period, which is 60 months
Secondary outcomes (6)
Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC
Measured: through study completion, an average of 7 year
Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC
Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC
Measured: through study completion, an average of 7 year
Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC
Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC
Measured: through study completion, an average of 7 year
Study the HVEM/BTLA axis in localized and advanced NSCLC
Association between HVEM expression and overall survival in localized and advanced NSCLC
Measured: through study completion, an average of 7 year
Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines
Percentage expression of co-signaling molecules, activating receptors, inhibitory receptors, as well as maturation, exhaustion, and proliferation markers of anti-tumor immune cells by mass cytometry (Appendix 1). Percentage expression of inflammatory cytokines by Luminex
Measured: through study completion, an average of 7 year
Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells
Levels of immune response in organoid cultures
Measured: through study completion, an average of 7 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start12 Feb 2026
- Primary completion12 May 2033 (estimated)
- Study completion12 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the study is interventional because there are blood and tumoral samples taken outside the scope of routine care
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608835
- Sponsor's protocol ID
- IMMUNOLUNG-IPC 2021-069
- Other IDs
- 2025-A00769-40
- Acronym
- IMMUNOLUNG
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069
- ClinicalTrials.gov ID
- NCT07608835
- Acronym / sponsor ID
- IMMUNOLUNG / IMMUNOLUNG-IPC 2021-069
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, immunotherapie, progression free survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 12 May 2033 (estimated)
- Study completion
- 12 May 2033 (estimated)
- First posted
- 27 May 2026 (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.
Immunotherapy has helped improve the prognosis of metastatic lung cancer. However, only about 40% of patients respond to conventional immunotherapy with anti-PD(L)-1 agents. This research aims to identify biomarkers of response to immunotherapy at the tumor level and to characterize new therapeutic targets
Detailed description
The primary objective of this clinical study is to understand how certain blood markers can predict the effectiveness of immunotherapy treatments for patients with advanced-stage lung cancer.
This is a multicenter study with a total duration of 7 years.
In addition, the study will address several secondary objectives:
Compare biological markers present in the blood with those found in lung cancer tumors.
Investigate differences between tumor markers at early versus advanced stages of the disease.
Identify new markers that may predict the effectiveness of immunotherapy treatments.
Explore a specific mechanism (called HVEM/BTLA) involved in lung cancer, whether at an early or advanced stage.
To achieve the study objectives, 200 patients are expected to be enrolled, and the study will be conducted across two institutions.
In this study, the following biological samples will be collected: blood and tissue samples at the time of inclusion, and again at disease progression if it occurs during follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the study is interventional because there are blood and tumoral samples taken outside the scope of routine care
| Arm | Type | Receives |
|---|---|---|
| patients with localized NSCLC | Other | Procedure: prospective collection of blood and tumor samplesThis project is based on the prospective collection of blood and tumor samples from NSCLC patients, along with the corresponding clinical data.One hundred patients with localized NSCLC will be enrolled at each participating center; these are patients with resectable NSCLC treated by surgery. |
| patients with advanced NSCLC | Other | Procedure: prospective collection of blood and tumor samplesOne hundred patients with advanced NSCLC will be enrolled at the center whose Principal Investigator is the scientific coordinator. These are patients with unresectable NSCLC who are not eligible for surgery and whose initial treatment consists of medical therapy (chemotherapy and/or immunotherapy). The samples are obtained using non-invasive techniques (mostly CT-guided biopsy and, less frequently, bronchoscopic or esophageal endoscopic biopsy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older, male or female.
- Willing to participate in the study and having signed a written informed consent form.
- Presenting a strong suspicion of localized resectable or advanced unresectable non-small cell lung cancer, or having a histologically confirmed non-small cell lung cancer.
- Affiliated with a social security system or benefiting from such a system.
Key exclusion criteria (4 listed)
- Individuals in an emergency situation, adults under legal protection (guardianship, curatorship, or judicial protection), or individuals unable to provide informed consent.
- Inability to comply with the medical follow-up required by the study for geographical, social, or psychological reasons.
- History of solid organ transplantation or hematopoietic stem cell transplantation.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| prospective collection of blood and tumor samplesThe procedure under study is based on the collection of tissue and blood samples at two time points during the patient's management. The patient will undergo a first sampling at the time of inclusion in the study, followed by a second sampling performed at the time of disease progression. Two types of samples will be collected: blood samples and tumor samples. The protocol-mandated tumor sampling at progression will be performed in the following two situations: 1. If, as part of routine clinical care, a biopsy is planned, an additional tumor sample for the study will be collected. 2. If the patient has consented to undergoing a protocol-specific tumor biopsy at the time of progression | Procedure or surgery | patients with advanced NSCLC, patients with localized NSCLC |
Primary outcome
"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC
Time frame: until the patient's death"or until the end of the patient follow-up period, which is 60 months
Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.
6 secondary outcomes
Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
Time frame: through study completion, an average of 7 year
Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC
Time frame: through study completion, an average of 7 year
Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC
Time frame: through study completion, an average of 7 year
Study the HVEM/BTLA axis in localized and advanced NSCLC
Time frame: through study completion, an average of 7 year
Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines
Time frame: through study completion, an average of 7 year
Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells
Time frame: through study completion, an average of 7 year
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 27 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prospective collection of blood and tumor samples in people with Non-small Cell Lung Cancer, run by Institut Paoli-Calmettes 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 4 inclusion and 4 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 27 May 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 Jihane pakradouni (0491223824, pakradounij@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"The primary objective is to assess the association between the immune signature in peripheral blood and the efficacy of immunotherapies in patients with advanced-stage NSCLC (time frame: until the patient's death"or until the end of the patient follow-up period, which is 60 months). 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 27 May 2026.