NCT04189679

Brief Summary

Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found. The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 3, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

January 3, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

3.1 years

First QC Date

October 3, 2019

Last Update Submit

January 15, 2024

Conditions

Non Small Cell Lung Cancer

Keywords

MetabolomicMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression

    To identify the link of the change from baseline of Metabolic signature in serum (metabolomics analysis performed using a Mass spectrometry) and the ICI response at 6 months or at the tumoral progression

    baseline, 6 months or tumoral progression

Secondary Outcomes (8)

  • Identification of the link between the Meta-genomic and immune signatures and the metabolic signature at 6 months or at the tumoral progression

    6 months or tumoral progression

  • Identification of the link between the Meta-genomic and immune signatures and ICI response at 6 months or at the tumoral progression

    6 months or tumoral progression

  • Description of the profile change of Meta-genomic signature

    2 months or tumoral progression

  • Description of the profile change of Immune signature at 2 months or at the tumoral progression

    Baseline and 2 months or tumoral progression

  • Identification of the link between the profile change of meta-genomic signature and the ICI response at 2 months or at the tumoral progression

    Baseline and (2 months or tumoral progression)

  • +3 more secondary outcomes

Study Arms (2)

First line

20 patients in first line of treatment

Other: Immune signature in serum associated to the metabolic signatureGenetic: Meta-genomic signature of intestinal flora

Second or third line

40 patients in second and third line of treatment

Other: Immune signature in serum associated to the metabolic signatureGenetic: Meta-genomic signature of intestinal flora

Interventions

Meta-genomic signature of intestinal floraGENETIC

Meta-genomic signature of intestinal flora

First lineSecond or third line
Immune signature in serum associated to the metabolic signatureOTHER

Immune signature in serum associated to the metabolic signature

First lineSecond or third line

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study cohort will include NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in Grenoble University Hospital (France) in 18 months. 60 NSCLC patients are anticipated to be enrolled in the study.

You may qualify if:

  • NSCLC diagnosis
  • Patient treated by a ICI in first, second or third line of treatment, or by the combination of chemotherapy and IPCI in first line of treatment
  • Patient with at least one measurable lesion as defined by RECIST

You may not qualify if:

  • Patient treated with antibiotic treatment within 2 weeks before the start of ICI or corticosteroids (\>20 mg per day) within 4 weeks before the start of ICI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Grenoble

La Tronche, Isère, 38700, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Meta-genomic signature of intestinal flora

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne-Claire Toffart, Dr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • Dalil Hannani, PhD

    Medicine University, Grenoble

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2019

First Posted

December 6, 2019

Study Start

January 3, 2020

Primary Completion

January 27, 2023

Study Completion

January 27, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)