Non-squamous Lung CancerRICEPSNCT04804137
Immune Response Under Immunotherapy in Metastatic NSCLC: Sputum, Blood Samples and Microbioata Study
An observational study of Non-squamous Lung Cancer and Metastatic Lung Cancer, run by University Hospital, Tours at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-squamous Lung Cancer, Metastatic Lung Cancer
- What is being tested?
- Blood, sputum and saliva
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 May 2021to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient under judicial protection
- Pregnant or breastfeeding women
- NSCLC of the epidermal or undifferentiated type
- Opposition to data processing
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Immune Response Under Immunotherapy in Metastatic Non-Small Cell Lung Cancer: Sputum, Blood Samples and Microbiota Study
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.
Read the 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.
- Conditions
- Non-squamous Lung Cancer, Metastatic Lung Cancer
- Being tested
- Blood, sputum, saliva, stool
- Keywords
- Blood sample, sputum, microbiota, Immunotherapy, saliva
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloodOther
Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.
sputumOther
induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.
salivaOther
spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group | adult patients with adenocarcinoma type non-small cell lung cancer Receives: Other: Blood; Other: sputum; Other: saliva; Other: stool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 30 months
Secondary outcomes (4)
Analysis of gut microbiota
characterisation of gut microbiota (16S rRNA sequencing)
Measured: 30 months
Analysis of lung microbiota
characterisation of lung microbiota (16S rRNA sequencing)
Measured: 30 months
perform blood pembrolizumab assays.
antibodies dosage
Measured: 30 months
perform sputum pembrolizumab assays.
antibodies dosage
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start3 May 2021
- Primary completion26 Sep 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-squamous Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor
- Investigators
- Marion FERREIRA, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804137
- Sponsor's protocol ID
- RIPH3-RNI20-RICEPS
- Acronym
- RICEPS
- Status last verified
- Jan 2024
- First submitted
- 8 Mar 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Immune Response Under Immunotherapy in Metastatic Non-Small Cell Lung Cancer: Sputum, Blood Samples and Microbiota Study
- ClinicalTrials.gov ID
- NCT04804137
- Acronym / sponsor ID
- RICEPS / RIPH3-RNI20-RICEPS
- Conditions
- Non-squamous Lung Cancer, Metastatic Lung Cancer
- Keywords
- Blood sample, sputum, microbiota, Immunotherapy, saliva
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 3 May 2021 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Mar 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Other: Blood, Other: sputum, Other: saliva, Other: stooladult patients with adenocarcinoma type non-small cell lung cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patient under judicial protection
- Pregnant or breastfeeding women
- NSCLC of the epidermal or undifferentiated type
- Opposition to data processing
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 |
|---|---|---|
| BloodBlood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy. | Other | Group |
| sputuminduced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy. | Other | Group |
| salivaspontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy. | Other | Group |
| stoolStool analyses will be carried out on a sample taken by the patient at home and brought back at the time of a day hospital. | Other | Group |
Primary outcome
Immune and inflammatory response in the blood
Time frame: 30 months
* 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)
Immune and inflammatory response in the airways
Time frame: 30 months
* 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)
4 secondary outcomes
Analysis of gut microbiota
Time frame: 30 months
Analysis of lung microbiota
Time frame: 30 months
perform blood pembrolizumab assays.
Time frame: 30 months
perform sputum pembrolizumab assays.
Time frame: 30 months
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: Undecided
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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.
Marion FERREIRA principal investigator
University Hospital, Tours
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-squamous Lung Cancer and Metastatic Lung Cancer, run by University Hospital, Tours at 2 sites in 2 countries.
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 5 inclusion and 4 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 2 sites in United States, 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?
Immune and inflammatory response in the blood (time frame: 30 months). The study lists 2 primary outcomes in all. 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.