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

NCT07608835 | Recruiting

• 2 other identifiers: IMMUNOLUNG-IPC 2021-0692025-A00769-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; immunotherapie; progression free survival

Outcome Measures

Primary Outcomes (1)

• "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 Outcomes (6)

• Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients

  through study completion, an average of 7 year

• Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC

  through study completion, an average of 7 year

• Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC

  through study completion, an average of 7 year

• Study the HVEM/BTLA axis 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

  through study completion, an average of 7 year

Study Arms (2)

patients with localized NSCLC

OTHER

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

patients with advanced NSCLC

OTHER

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

Interventions

prospective collection of blood and tumor samples PROCEDURE

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

patients with advanced NSCLC; patients with localized NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Rochigneux

Marseille, Institut Paoli Calmettes, 13009, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jihane pakradouni

CONTACT

0491223824; pakradounij@ipc.unicancer.fr

allison arthur

CONTACT

0491223448; arthura@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: the study is interventional because there are blood and tumoral samples taken outside the scope of routine care

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: May 27, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): May 12, 2033
• Study Completion (Estimated): May 12, 2033
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

FR (1)