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NCT Number: NCT07608835

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rochigneux

Marseille, Institut Paoli Calmettes, 13009, France

Location status: Recruiting

Location contact

allison ARTHUR

CONTACT

0491223448

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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:

  • 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

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

    Time frame: until the patient's death"or until the end of the patient follow-up period, which is 60 months

    Overall survival of patients with advanced-stage NSCLC treated with immunotherapy according to their immune signature.

Secondary outcomes

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

    Time frame: through study completion, an average of 7 year

    Frequency of Immune Biomarkers in the Blood and Tumor Microenvironment of NSCLC

  2. 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

    Frequency of Immune Biomarkers in the Tumor Microenvironment of Localized and Advanced NSCLC

  3. Identify new immune biomarkers predictive of immunotherapy efficacy in advanced NSCLC

    Time frame: through study completion, an average of 7 year

    Frequency of Novel Immune Biomarkers According to Response to Immunotherapies in Advanced NSCLC

  4. Study the HVEM/BTLA axis in localized and advanced NSCLC

    Time frame: through study completion, an average of 7 year

    Association between HVEM expression and overall survival in localized and advanced NSCLC

  5. 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

    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

  6. 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

    Levels of immune response in organoid cultures

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane pakradouni

CONTACT

[email protected]

0491223824

allison arthur

CONTACT

[email protected]

0491223448

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: IMMUNOLUNG

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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