Lung CancerIMMUNO-PREDICTNCT02827344
PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer
An observational study of Lung Cancer, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- blood sample collection for CTC and MDSC analysis
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to Dec 2021
- 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: Stage IV non small lung cancer patients
Who may be able to join
- Stage IV non-small cell lung cancer patient prior to start immunotherapy treatment
- Patients with World Health Organization (WHO) performance status 0-3
- Patients who were informed and had non opposition form signed by investigator
- Patients with healthcare insurance system affiliation
Who cannot join
- Prior malignancy within 5 years of study entry
- Refusal to participate
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of PD-L1 Expression Analysis on Circulating Tumor Cells by Immunocytochemistry and MDSCs Level Evolution Analysis in Non-small Cell Lung Cancer Treated With PD-L1 or PD1 Inhibitor
Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.
Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs.
The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC
- Conditions
- Lung Cancer
- Being tested
- blood sample collection for CTC and MDSC analysis
- Keywords
- PD-1/PD-L1, Immune checkpoints, Immunotherapy, lung cancer, circulating tumor cells, immunocytochemistry, ISET, MDSC, Stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Neoplastic Cells, Circulating, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collection for CTC and MDSC analysisBiological
- Isolation of circulating tumor cells from 2 tubes by ISET filtration module. Peripheral blood samples will be collected for CTC analysis within 7 days before commencing treatment (defined as baseline) and following four cycles of immunotherapy,
- Analysis of PD-L1 and PD-L2 expression by immunocytochemistry on CTC
- Analysis of the expression of PD-L1, PD-L2 , CTLA4 on the histological specimen by immunohistochemistry
| Study group | Role | What they receive |
|---|---|---|
| Stage IV non-small cell lung cancer | Intervention to be done are :
- Blood sample collection for CTC and MDSC analysis Receives: Biological: blood sample collection for CTC and MDSC analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of analysis of PDL-1 expression on circulating tumor cells as assessed by immunocytochemistry analysis
Prior to immunotherapy, after four cycle of immunotherapy
Measured: Through the end of study (12 months)
Secondary outcomes (2)
Percentage of CTC expressing PD-L1 after four cycle of immunotherapy as assessed by immunocytochemistry analysis
Prior to immunotherapy, after four cycle of immunotherapy
Measured: Through the end of study (12 months)
Evolution of MDSCs count in response to treatment as assessed by MDSCs analysis
Prior to immunotherapy, after four cycle of immunotherapy
Measured: Through the end of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Oct 2015
- Primary completionOct 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GUIBERT, PH, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827344
- Sponsor's protocol ID
- 15 7737 02
- Acronym
- IMMUNO-PREDICT
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2016
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guibert N, Jones G, Beeler JF, Plagnol V, Morris C, Mourlanette J, Delaunay M, Keller L, Rouquette I, Favre G, Pradines A, Mazieres J. Targeted sequencing of plasma cell-free DNA to predict response to PD1 inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2019 Nov;137:1-6. doi: 10.1016/j.lungcan.2019.09.005. Epub 2019 Sep 6.
PubMed 31518912Guibert N, Pradines A, Favre G, Mazieres J. [Finding mutations of interest in circulating tumor DNA helps predict immunotherapy response in lung cancer]. Med Sci (Paris). 2020 May;36(5):437-439. doi: 10.1051/medsci/2020068. Epub 2020 May 26. No abstract available. French.
PubMed 32452359
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of PD-L1 Expression Analysis on Circulating Tumor Cells by Immunocytochemistry and MDSCs Level Evolution Analysis in Non-small Cell Lung Cancer Treated With PD-L1 or PD1 Inhibitor
- ClinicalTrials.gov ID
- NCT02827344
- Acronym / sponsor ID
- IMMUNO-PREDICT / 15 7737 02
- Conditions
- Lung Cancer
- Keywords
- PD-1/PD-L1, Immune checkpoints, Immunotherapy, lung cancer, circulating tumor cells, immunocytochemistry, ISET, MDSC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.
Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs.
The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage IV non-small cell lung cancer | – | Biological: blood sample collection for CTC and MDSC analysisIntervention to be done are : - Blood sample collection for CTC and MDSC analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IV non small lung cancer patients
Key inclusion criteria (4 listed)
- Stage IV non-small cell lung cancer patient prior to start immunotherapy treatment
- Patients with World Health Organization (WHO) performance status 0-3
- Patients who were informed and had non opposition form signed by investigator
- Patients with healthcare insurance system affiliation
Key exclusion criteria (3 listed)
- Prior malignancy within 5 years of study entry
- Refusal to participate
- Patient under legal protection
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 |
|---|---|---|
| blood sample collection for CTC and MDSC analysis* Isolation of circulating tumor cells from 2 tubes by ISET filtration module. Peripheral blood samples will be collected for CTC analysis within 7 days before commencing treatment (defined as baseline) and following four cycles of immunotherapy, * Analysis of PD-L1 and PD-L2 expression by immunocytochemistry on CTC * Analysis of the expression of PD-L1, PD-L2 , CTLA4 on the histological specimen by immunohistochemistry | Biological | Stage IV non-small cell lung cancer |
Primary outcome
Feasibility of analysis of PDL-1 expression on circulating tumor cells as assessed by immunocytochemistry analysis
Time frame: Through the end of study (12 months)
Prior to immunotherapy, after four cycle of immunotherapy
2 secondary outcomes
Percentage of CTC expressing PD-L1 after four cycle of immunotherapy as assessed by immunocytochemistry analysis
Time frame: Through the end of study (12 months)
Evolution of MDSCs count in response to treatment as assessed by MDSCs analysis
Time frame: Through the end of study (12 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 29 Aug 2023.
- Results publication: PubMed 31518912Guibert N, Jones G, Beeler JF, Plagnol V, Morris C, Mourlanette J, Delaunay M, Keller L, Rouquette I, Favre G, Pradines A, Mazieres J. Targeted sequencing of plasma cell-free DNA to predict response to PD1 inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2019 Nov;137:1-6. doi: 10.1016/j.lungcan.2019.09.005. Epub 2019 Sep 6.
- Results publication: PubMed 32452359Guibert N, Pradines A, Favre G, Mazieres J. [Finding mutations of interest in circulating tumor DNA helps predict immunotherapy response in lung cancer]. Med Sci (Paris). 2020 May;36(5):437-439. doi: 10.1051/medsci/2020068. Epub 2020 May 26. No abstract available. French.
- 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.
Nicolas GUIBERT, PH principal investigator
University Hospital of Toulouse
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 Lung Cancer, run by University Hospital, Toulouse 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 4 inclusion and 3 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 29 Aug 2023. 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?
Feasibility of analysis of PDL-1 expression on circulating tumor cells as assessed by immunocytochemistry analysis (time frame: Through the end of study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827344, which also lists 2 linked publications.
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 29 Aug 2023.