IMMUNO-LUNG : Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy

Официальное название

IMMUNO-LUNG: Identification of Biomarkers and Therapeutic Targets for Pulmonary Immunotherapy - IMMUNOLUNG-IPC 2021-069

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура prospective 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 clinic

Первичные конечные точки

• "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 [Срок оценки: until the patient's death"or until the end of the patient follow-up period, which is 60 months]

Вторичные конечные точки (6)

• Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients [Срок оценки: through study completion, an average of 7 year]
• Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC [Срок оценки: through study completion, an average of 7 year]
• Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC [Срок оценки: through study completion, an average of 7 year]
• Study the HVEM/BTLA axis in localized and advanced NSCLC [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through study completion, an average of 7 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Rochigneux — Marseille

Идентификаторы

NCT: NCT07608835 · IMMUNOLUNG-IPC 2021-069 · 2025-A00769-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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