NCT04804137

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

March 8, 2021

Last Update Submit

January 16, 2024

Conditions

Non-squamous Lung CancerMetastatic Lung Cancer

Keywords

Blood samplesputummicrobiotaImmunotherapysaliva

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Analysis of gut microbiota

    30 months

  • Analysis of lung microbiota

    30 months

  • perform blood pembrolizumab assays.

    30 months

  • perform sputum pembrolizumab assays.

    30 months

Study Arms (1)

Group

adult patients with adenocarcinoma type non-small cell lung cancer

Other: BloodOther: sputumOther: salivaOther: stool

Interventions

BloodOTHER

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

Group
sputumOTHER

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

Group
salivaOTHER

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

Group
stoolOTHER

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.

Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ferreira Marion

Los Angeles, California, 90048, United States

Location

University hospital

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample, stool, saliva, sputum

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen CollectionDefecation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Marion FERREIRA

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 18, 2021

Study Start

May 3, 2021

Primary Completion

September 26, 2022

Study Completion

July 31, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

FR(1)US(1)