IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy (IMMUNOLUNG)
IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jihane pakradouni
- Número de teléfono: 0491223824
- Correo electrónico: pakradounij@ipc.unicancer.fr
Copia de seguridad de contactos de estudio
- Nombre: allison arthur
- Número de teléfono: 0491223448
- Correo electrónico: arthura@ipc.unicancer.fr
Ubicaciones de estudio
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Institut Paoli Calmettes
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Marseille, Institut Paoli Calmettes, Francia, 13009
- Reclutamiento
- Rochigneux
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Contacto:
- allison ARTHUR
- Número de teléfono: 0491223448
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: patients with localized NSCLC
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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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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Otro: patients with advanced NSCLC
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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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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"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
Periodo de tiempo: until the patient's death"or until the end of the patient follow-up period, which is 60 months
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Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.
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until the patient's death"or until the end of the patient follow-up period, which is 60 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
Periodo de tiempo: through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC
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through study completion, an average of 7 year
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Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC
Periodo de tiempo: through study completion, an average of 7 year
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Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC
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through study completion, an average of 7 year
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Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC
Periodo de tiempo: through study completion, an average of 7 year
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Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC
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through study completion, an average of 7 year
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Study the HVEM/BTLA axis in localized and advanced NSCLC
Periodo de tiempo: through study completion, an average of 7 year
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Association between HVEM expression and overall survival in localized and advanced NSCLC
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through study completion, an average of 7 year
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Analyze co-signaling molecules, activating receptors, inhibitory receptors, as well as the maturation, exhaustion, and proliferation of anti-tumor immune cells, and cytokines
Periodo de tiempo: through study completion, an average of 7 year
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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
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through study completion, an average of 7 year
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Analyze the impact of the tumor and its microenvironment on the phenotype of anti-tumor immune cells
Periodo de tiempo: through study completion, an average of 7 year
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Levels of immune response in organoid cultures
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through study completion, an average of 7 year
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IMMUNOLUNG-IPC 2021-069
- 2025-A00769-40 (Identificador de registro: Numéro ID RCB)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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