Non Small Cell Lung CancerMETABO-ICINCT04189679
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Grenoble at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Immune signature in serum associated to the metabolic signature and Meta-genomic signature of intestinal flora
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2020to 27 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: : 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
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Immune signature in serum associated to the metabolic signature, Meta-genomic signature of intestinal flora
- Keywords
- Metabolomic, Microbiota
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune signature in serum associated to the metabolic signatureOther
Immune signature in serum associated to the metabolic signature
Meta-genomic signature of intestinal floraGenetic
Meta-genomic signature of intestinal flora
| Study group | Role | What they receive |
|---|---|---|
| First line | 20 patients in first line of treatment Receives: Other: Immune signature in serum associated to the metabolic signature; Genetic: Meta-genomic signature of intestinal flora | |
| Second or third line | 40 patients in second and third line of treatment Receives: Other: Immune signature in serum associated to the metabolic signature; Genetic: Meta-genomic signature of intestinal flora |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 6 months or tumoral progression
Description of the profile change of Meta-genomic signature
To describe the change from baseline of the Meta-genomic signature at 2 months or at the tumoral progression
Measured: 2 months or tumoral progression
Description of the profile change of Immune signature at 2 months or at the tumoral progression
To describe the change from baseline of the Immune signature at 2 months or at the tumoral progression
Measured: 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
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
Measured: 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
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
Measured: Baseline and (2 months or tumoral progression)
Description of overall survival under ICI at 6 months or at the tumoral progression
To describe of the overall survival under ICI at 6 months or at the tumoral progression
Measured: 6 months or tumoral progression
Description of the survival without progression under ICI at 6 months or at the tumoral progression
To describe the survival without progression under ICI at 6 months or at the tumoral progression
Measured: 6 months or tumoral progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start3 Jan 2020
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Claire Toffart, Dr, Principal investigator, University Hospital, GrenobleDalil Hannani, PhD, Study director, Medicine University, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189679
- Sponsor's protocol ID
- 38RC19.133
- Other IDs
- 2019-A01255-52
- Acronym
- METABO-ICI
- Status last verified
- Jan 2024
- First submitted
- 3 Oct 2019
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- : Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT04189679
- Acronym / sponsor ID
- METABO-ICI / 38RC19.133
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Metabolomic, Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First line | – | Other: Immune signature in serum associated to the metabolic signature, Genetic: Meta-genomic signature of intestinal flora20 patients in first line of treatment |
| Second or third line | – | Other: Immune signature in serum associated to the metabolic signature, Genetic: Meta-genomic signature of intestinal flora40 patients in second and third line of treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune signature in serum associated to the metabolic signatureImmune signature in serum associated to the metabolic signature | Other | First line, Second or third line |
| Meta-genomic signature of intestinal floraMeta-genomic signature of intestinal flora | Genetic | First line, Second or third line |
Primary outcome
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
8 secondary outcomes
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
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
Description of the profile change of Meta-genomic signature
Time frame: 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
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)
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)
Description of overall survival under ICI at 6 months or at the tumoral progression
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Claire Toffart, Dr principal investigator
University Hospital, Grenoble
Dalil Hannani, PhD study director
Medicine University, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.