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

Completed

• Conditions: Lung Cancer
• Interventions: Biological: blood sample collection for CTC and MDSC analysis

• Registration Number: NCT02827344
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Primary Completion: 2021-10
• Study Completion: 2021-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage IV non-small cell lung cancer	blood sample collection for CTC and MDSC analysis	Intervention to be done are : - Blood sample collection for CTC and MDSC analysis

Primary Outcome Measures

Name	Time	Method
Feasibility of analysis of PDL-1 expression on circulating tumor cells as assessed by immunocytochemistry analysis	Through the end of study (12 months)	Prior to immunotherapy, after four cycle of immunotherapy

Secondary Outcome Measures

Name	Time	Method
Percentage of CTC expressing PD-L1 after four cycle of immunotherapy as assessed by immunocytochemistry analysis	Through the end of study (12 months)	Prior to immunotherapy, after four cycle of immunotherapy
Evolution of MDSCs count in response to treatment as assessed by MDSCs analysis	Through the end of study (12 months)	Prior to immunotherapy, after four cycle of immunotherapy

Trial Locations

Locations (1)

Larrey Hospital; 🇫🇷 Toulouse, France