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PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer (IMMUNO-PREDICT)

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ClinicalTrials.gov Identifier: NCT02827344
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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. 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


Condition or disease Intervention/treatment
Lung Cancer Biological: blood sample collection for CTC and MDSC analysis

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Stage IV non-small cell lung cancer

Intervention to be done are :

- Blood sample collection for CTC and MDSC analysis

Biological: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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) ]
    Prior to immunotherapy, after four cycle of immunotherapy

  2. Evolution of MDSCs count in response to treatment as assessed by MDSCs analysis [ Time Frame: Through the end of study (12 months) ]
    Prior to immunotherapy, after four cycle of immunotherapy


Biospecimen Retention:   Samples With DNA
  • Peripheral blood sample
  • Circulating tumor cells isolated from peripheral blood sample
  • MDSCs : immature myeloid cells that inhibit T cell functions rate analysis from peripheral blood sample
  • Tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stage IV non small lung cancer patients
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior malignancy within 5 years of study entry
  • Refusal to participate
  • Patient under legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827344


Contacts
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Contact: Nicolas GUIBERT, PH 5 67 77 81 60 ext +33 guibert.n@chu-toulouse.fr
Contact: Julien Mazieres, PU-PH 5 67 77 18 31 mazieres.j@chu-toulouse.fr

Locations
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France
Larrey Hospital Recruiting
Toulouse, France, 31059
Contact: Sandrine GOUIN    5 67 77 14 49 ext +33    gouin.s@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Nicolas GUIBERT, PH University Hospital of Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02827344    
Other Study ID Numbers: 15 7737 02
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
PD-1/PD-L1
Immune checkpoints
Immunotherapy
lung cancer
circulating tumor cells
immunocytochemistry
ISET
MDSC
Stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplastic Cells, Circulating
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes