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

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

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Procedure: prospective collection of blood and tumor samples

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jihane pakradouni; Phone Number: 0491223824; Email: pakradounij@ipc.unicancer.fr
• Study Contact Backup: Name: allison arthur; Phone Number: 0491223448; Email: arthura@ipc.unicancer.fr

Study Locations

• France
  • Institut Paoli Calmettes
    • Marseille, Institut Paoli Calmettes, France, 13009
      • Recruiting
      • Rochigneux
      • Contact: allison ARTHUR; Phone Number: 0491223448

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: 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: If, as part of routine clinical care, a biopsy is planned, an additional tumor sample for the study will be collected.; If the patient has consented to undergoing a protocol-specific tumor biopsy at the time of progression
Other: 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).	Procedure: 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: If, as part of routine clinical care, a biopsy is planned, an additional tumor sample for the study will be collected.; If the patient has consented to undergoing a protocol-specific tumor biopsy at the time of progression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): May 12, 2033
• Study Completion (Estimated): May 12, 2033

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer; progression free survival; immunotherapie
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IMMUNOLUNG-IPC 2021-069; 2025-A00769-40 (Registry Identifier: Numéro ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No