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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00769-40 | Registry Identifier | Numéro ID RCB |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prospective collection of blood and tumor samples | Procedure | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| "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. | until the patient's death"or until the end of the patient follow-up period, which is 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average of 7 year |
| Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihane pakradouni | Contact | 0491223824 | pakradounij@ipc.unicancer.fr | |
| allison arthur | Contact | 0491223448 | arthura@ipc.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochigneux | Recruiting | Marseille | Institut Paoli Calmettes | 13009 | France |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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the study is interventional because there are blood and tumoral samples taken outside the scope of routine care
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|
Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC |
| 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 | 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 | 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 | 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 | through study completion, an average of 7 year |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |