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NCT Number: NCT02827344

PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample collection for CTC and MDSC analysis

Biological
  • 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: IMMUNO-PREDICT

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 11, 2016
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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