Non-small Cell Lung Cancer
Conditions
Keywords
lung cancer, immunotherapie, progression free survival
Brief 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
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.
Interventions
PROCEDUREprospective collection of blood and tumor samples
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: 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
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
the study is interventional because there are blood and tumoral samples taken outside the scope of routine care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| "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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients | through study completion, an average of 7 year | Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC |
| Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC | through study completion, an average of 7 year | Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC |
| Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC | through study completion, an average of 7 year | Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC |
| Study the HVEM/BTLA axis in localized and advanced NSCLC | through study completion, an average of 7 year | Association between HVEM expression and overall survival in localized and advanced NSCLC |
| Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines | through study completion, an average of 7 year | 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 |
| Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells | through study completion, an average of 7 year | Levels of immune response in organoid cultures |
Countries
France
Contacts
CONTACTJihane pakradouni
CONTACTallison arthur
Outcome results
None listed