Clinical trial NCT04804137: Immune Response Under Immunotherapy in Metastatic NSCLC: Sputum, Blood Samples and Microbioata Study
Official title: Immune Response Under Immunotherapy in Metastatic Non-Small Cell Lung Cancer: Sputum, Blood Samples and Microbiota Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-squamous Lung Cancer
Metastatic Lung Cancer
Keywords: Blood sample
sputum
microbiota
Immunotherapy
saliva
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Cedars-Sinai Medical Center
First posted: 2021-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients suffering from adenocarcinoma type non-small cell lung cancer (NSCLC) without oncogenic addiction, metastatic, treated by ICI alone or in combination with 1st line chemotherapy at the Tours CHRU.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immune and inflammatory response in the blood
timeFrame: 30 months
measure: Immune and inflammatory response in the airways
timeFrame: 30 months
Secondary outcomes:
measure: Analysis of gut microbiota
timeFrame: 30 months
measure: Analysis of lung microbiota
timeFrame: 30 months
measure: perform blood pembrolizumab assays.
timeFrame: 30 months
measure: perform sputum pembrolizumab assays.
timeFrame: 30 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ferreira Marion
state: California
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Marion FERREIRA
role: PRINCIPAL_INVESTIGATOR
References: