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

19. maj 2026 opdateret af: Institut Paoli-Calmettes

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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
    • Institut Paoli Calmettes
      • Marseille, Institut Paoli Calmettes, Frankrig, 13009
        • Rekruttering
        • Rochigneux
        • Kontakt:
          • allison ARTHUR
          • Telefonnummer: 0491223448

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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:

  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
Andet: 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:

  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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
"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
Tidsramme: 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.
until the patient's death"or until the end of the patient follow-up period, which is 60 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare immune biomarkers in the blood and in the tumor microenvironment of NSCLC patients
Tidsramme: through study completion, an average of 7 year
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
Tidsramme: through study completion, an average of 7 year
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
Tidsramme: through study completion, an average of 7 year
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
Tidsramme: through study completion, an average of 7 year
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
Tidsramme: 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
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
Tidsramme: through study completion, an average of 7 year
Levels of immune response in organoid cultures
through study completion, an average of 7 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut Paoli-Calmettes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. februar 2026

Primær færdiggørelse (Anslået)

12. maj 2033

Studieafslutning (Anslået)

12. maj 2033

Datoer for studieregistrering

Først indsendt

11. februar 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IMMUNOLUNG-IPC 2021-069
  • 2025-A00769-40 (Registry Identifier: Numéro ID RCB)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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