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Recruiting NCT07608835

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

No phase Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: prospective collection of blood and tumor samples.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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.

Interventions

  • 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: 1. If, as part of routine clinic

Primary outcome measures

  • "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 [Time frame: until the patient's death"or until the end of the patient follow-up period, which is 60 months]
Secondary outcome measures (6)
  • Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients [Time frame: through study completion, an average of 7 year]
  • Compare the expression of immune biomarkers in the tumor microenvironment of localized versus advanced NSCLC [Time frame: through study completion, an average of 7 year]
  • Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC [Time frame: through study completion, an average of 7 year]
  • Study the HVEM/BTLA axis in localized and advanced NSCLC [Time frame: 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 [Time frame: 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 [Time frame: through study completion, an average of 7 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Rochigneux — Marseille

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗