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

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

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.

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.