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NCT Number: NCT04804137

Immune Response Under Immunotherapy in Metastatic NSCLC: Sputum, Blood Samples and Microbioata Study

Prospective pathophysiological exploratory monocentric study, focusing on adult patients with non-small cell lung cancer (NSCLC) : non-squamous type without oncogenic addiction, metastatic, treated with immune checkpoint inhibitors alone or in combination with chemotherapy in front line at the CHRU de Tours, France.

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Key information

Conditions

Non-squamous Lung Cancer Lung Diseases Lung Neoplasms Metastatic Lung Cancer Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital, Tours, France

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About this study

The percentage of patients benefiting from immunotherapy is quite low and their systemic side effects can sometimes be severe. One of the main difficulties is to identify before treatment patients who will respond to immune checkpoint inhibitors. Currently, the selection is done in a very large majority of cases on the expression of PD-L1 by the tumor. But this biomarker is not sufficient to identify patients responding or not to immune checkpoint inhibitors. In addition, factors extrinsic to the tumor, to its microenvironment and patient immunity may be involved in the response to immunotherapy such as the microbiota.

The investigators therefore assume that the immune response in place during immunotherapy treatment differs according to the profile of patient response to immunotherapy.

The main objective of this project is to describe local and systemic anti-tumor immune system of patients responders or not to immune checkpoint inhibitors, but also whether the immunological characterization of sputum could be a reflection of the microenvironment tumor. The secondary objective is to study the intestinal microbiota tract of patients receiving immunotherapy, depending on their consumption of antibiotics, and compare it to the pulmonary microbiota.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of 18 years or over
  • Diagnosis of metastatic NSCLC (Stage IV) adenocarcinoma only
  • Absence of oncogenic addiction (EGFR, ALK, ROS1, RET, MET, BRAF)
  • Treatment with ICI anti-PD1 or anti-PDL1 (pembrolizumab or atezolizumab) as 1st line treatment alone or in combination with chemotherapy and/or anti-angiogenic (bevacizumab).
  • 1st injection of ICI, whether or not combined with chemotherapy

Exclusion criteria

  • Patient under judicial protection
  • Pregnant or breastfeeding women
  • NSCLC of the epidermal or undifferentiated type
  • Opposition to data processing

Treatment and study plan

Blood

Other

Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.

Sputum

Other

induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.

saliva

Other

spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.

stool

Other

Stool analyses will be carried out on a sample taken by the patient at home and brought back at the time of a day hospital.

Primary outcomes

  1. Immune and inflammatory response in the blood

    Time frame: 30 months

    • T cell sub populations assessed by their relative abundance, and will be expressed as a percentage of total T cells
    • B lymphocytes
    • Cytokine inflammatory profile: the level of activation/regulation, production of cytokines and cytotoxicity markers will be analysed as a percentage of cells expressing the markers or producing the cytokines in relation to the total cell population (e.g. HLA-DR+, CD38+, Bcl-2lo phenotype of CD8 T lymphocytes)

  2. Immune and inflammatory response in the airways

    Time frame: 30 months

    • T cell sub populations assessed by their relative abundance, and will be expressed as a percentage of total T cells
    • B lymphocytes
    • Cytokine inflammatory profile: the level of activation/regulation, production of cytokines and cytotoxicity markers will be analysed as a percentage of cells expressing the markers or producing the cytokines in relation to the total cell population (e.g. HLA-DR+, CD38+, Bcl-2lo phenotype of CD8 T lymphocytes)

Secondary outcomes

  1. Analysis of gut microbiota

    Time frame: 30 months

    characterisation of gut microbiota (16S rRNA sequencing)

  2. Analysis of lung microbiota

    Time frame: 30 months

    characterisation of lung microbiota (16S rRNA sequencing)

  3. perform blood pembrolizumab assays.

    Time frame: 30 months

    antibodies dosage

  4. perform sputum pembrolizumab assays.

    Time frame: 30 months

    antibodies dosage

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Cedars-Sinai Medical Center

Registry information

Official study title

Immune Response Under Immunotherapy in Metastatic Non-Small Cell Lung Cancer: Sputum, Blood Samples and Microbiota Study

Acronym: RICEPS

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Jan 17, 2024

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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