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

Lung Cancer Clinical Trial

— IMMUNO-PREDICT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827344
• Other study ID #: 15 7737 02
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: December 2021

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms
• Neoplastic Cells, Circulating

Intervention

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

Locations

Country	Name	City	State
France	Larrey Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View Citation

Guibert 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 a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of analysis of PDL-1 expression on circulating tumor cells as assessed by immunocytochemistry analysis	Prior to immunotherapy, after four cycle of immunotherapy	Through the end of study (12 months)
Secondary	Percentage of CTC expressing PD-L1 after four cycle of immunotherapy as assessed by immunocytochemistry analysis	Prior to immunotherapy, after four cycle of immunotherapy	Through the end of study (12 months)
Secondary	Evolution of MDSCs count in response to treatment as assessed by MDSCs analysis	Prior to immunotherapy, after four cycle of immunotherapy	Through the end of study (12 months)