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

Metastatic Lung Cancer Clinical Trial

— RICEPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804137
• Other study ID #: RIPH3-RNI20-RICEPS
• Status: Completed
• Start date: May 3, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 31, 2023
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Metastatic Lung Cancer
• Non-squamous Lung Cancer

Intervention

Other:
• Blood
Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.
• sputum
induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.
• saliva
spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.
• stool
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.

Locations

Country	Name	City	State
France	University hospital	Tours
United States	Ferreira Marion	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Cedars-Sinai Medical Center

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune and inflammatory response in the blood	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)	30 months
Primary	Immune and inflammatory response in the airways	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)	30 months
Secondary	Analysis of gut microbiota	characterisation of gut microbiota (16S rRNA sequencing)	30 months
Secondary	Analysis of lung microbiota	characterisation of lung microbiota (16S rRNA sequencing)	30 months
Secondary	perform blood pembrolizumab assays.	antibodies dosage	30 months
Secondary	perform sputum pembrolizumab assays.	antibodies dosage	30 months