- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04189679
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma (METABO-ICI)
: Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
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
Study Overview
Status
Conditions
Detailed Description
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI.
Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any.
In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Isère
-
La Tronche, Isère, France, 38700
- University Hospital, Grenoble
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
First line
20 patients in first line of treatment
|
Immune signature in serum associated to the metabolic signature
Meta-genomic signature of intestinal flora
|
Second or third line
40 patients in second and third line of treatment
|
Immune signature in serum associated to the metabolic signature
Meta-genomic signature of intestinal flora
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression
Time Frame: baseline, 6 months or 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of the link between the Meta-genomic and immune signatures and the metabolic signature at 6 months or at the tumoral progression
Time Frame: 6 months or tumoral progression
|
To identify the link between the Meta-genomic signature of intestinal flora (microbiota composition analysed by RNA 16 S) with the Immune signature in serum 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
Time Frame: 6 months or tumoral progression
|
To identify the link between the Meta-genomic signature of intestinal flora with the Immune signature in serum and the ICI response at 6 months or at the tumoral progression
|
6 months or tumoral progression
|
Description of the profile change of Meta-genomic signature
Time Frame: 2 months or tumoral progression
|
To describe the change from baseline of the Meta-genomic signature at 2 months or at the tumoral progression
|
2 months or tumoral progression
|
Description of the profile change of Immune signature at 2 months or at the tumoral progression
Time Frame: Baseline and 2 months or tumoral progression
|
To describe the change from baseline of the 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
Time Frame: Baseline and (2 months or tumoral progression)
|
To identify the link between the profile change from baseline of meta-genomic signature and the ICI response at 2 months or at the tumoral progression
|
Baseline and (2 months or tumoral progression)
|
Identification of change of immune signature and the ICI response at 2 months or at the tumoral progression
Time Frame: Baseline and (2 months or tumoral progression)
|
To identify the link between the profile change from baseline of immune signature and the ICI response at 2 months or at the tumoral progression
|
Baseline and (2 months or tumoral progression)
|
Description of overall survival under ICI at 6 months or at the tumoral progression
Time Frame: 6 months or tumoral progression
|
To describe of the overall survival under ICI at 6 months or at the tumoral progression
|
6 months or tumoral progression
|
Description of the survival without progression under ICI at 6 months or at the tumoral progression
Time Frame: 6 months or tumoral progression
|
To describe the survival without progression under ICI at 6 months or at the tumoral progression
|
6 months or tumoral progression
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Claire Toffart, Dr, University Hospital, Grenoble
- Study Director: Dalil Hannani, PhD, Medicine University, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC19.133
- 2019-A01255-52 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on Immune signature in serum associated to the metabolic signature
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH)Completed
-
Azienda Socio Sanitaria Territoriale degli Spedali...Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Istituti Ospitalieri... and other collaboratorsNot yet recruitingSquamous Cell Carcinoma of the Skin
-
Hôpital le VinatierHospices Civils de LyonCompleted
-
University of PennsylvaniaCompleted
-
University of Rome Tor VergataCompletedLiver Transplantation | SARS-CoV-2 VaccinationItaly
-
Xuzhou Medical UniversityRecruitingLung Squamous Cell CarcinomaChina
-
Jagiellonian UniversityRecruiting
-
Memorial Sloan Kettering Cancer CenterPfizer; Dana-Farber Cancer Institute; University of Pittsburgh; University of VirginiaCompletedNeurofibromatosis | Meningioma | CNS Cancer | Hemangioblastoma | Intracranial HemangiopericytomaUnited States