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

19. mai 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Frankrike
    • Institut Paoli Calmettes
      • Marseille, Institut Paoli Calmettes, Frankrike, 13009
        • Rekruttering
        • Rochigneux
        • Ta kontakt med:
          • allison ARTHUR
          • Telefonnummer: 0491223448

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Fremgangsmåte: 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
Annen: 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).
Fremgangsmåte: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Institut Paoli-Calmettes

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. februar 2026

Primær fullføring (Antatt)

12. mai 2033

Studiet fullført (Antatt)

12. mai 2033

Datoer for studieregistrering

Først innsendt

11. februar 2026

Først innsendt som oppfylte QC-kriteriene

19. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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