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

  • STATUS
    Recruiting
  • End date
    Mar 26, 2025
  • participants needed
    80
  • sponsor
    University Hospital, Tours
Updated on 26 May 2022

Summary

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.

Description

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.

Details
Condition Non-squamous Lung Cancer, Metastatic Lung Cancer
Treatment Blood, sputum, saliva, Stool
Clinical Study IdentifierNCT04804137
SponsorUniversity Hospital, Tours
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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)
st 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
Clear my responses

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