PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC). (PROTEON)

PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).

This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: induced sputum; Diagnostic test: lung biopsy; Diagnostic test: bronchoalveolar lavage; Diagnostic test: blood draw

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Sibille, MD; Phone Number: +3243237452; Email: anne.sibille@chuliege.be
• Study Contact Backup: Name: Aurore Cue Alvarez; Phone Number: +3243235539; Email: aurore.cuealvarez@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège
    • Contact: Aurore Cue Alvarez; Phone Number: +3243235539; Email: aurore.cuealvarez@chuliege.be
    • Contact: Anne Sibille, MD; Phone Number: +3243237400; Email: anne.sibille@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• o All stages of NSCLC

  • Stage III-IV NSCLC eligible for ICI treatment
  • 18 years or older; non pregnant women
  • in stage III-IV: no previous ICI and before ICI (mono- or combination therapy) initiation
  • Signed informed consent
  • Clinical, biological and radiological evaluation at the CHU de Liège for at least 6 months following treatment initiation

Exclusion Criteria:

• Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors)
• Inclusion in a clinical study contraindicating the enrolment in the PROTEON study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Eosinophil detection; Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.

Diagnostic test: induced sputum; After premedication with 400 μg inhaled salbutamol, sputum will be induced by inhalation of hypertonic (NaCl 3%) or isotonic (NaCl 0.9%) saline combined according to the FEV-1 value (> or ≤ than 65% predicted). Saline will be combined with additional salbutamol delivered by an ultrasonic nebulizer (Ultra-Neb 2000; Devilbiss, Somerset, PA, USA) with an output set at 0.9 ml/min. Each subject will inhale the aerosol for three consecutive periods of 5 min for a total of 15 min. For safety reasons, FEV-1 will be monitored throughout the induction and will be stopped if FEV-1 would fall by more than 20% from baseline.; Diagnostic test: lung biopsy; As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.; Diagnostic test: bronchoalveolar lavage; When available, the remaining material from a patient's bronchoalveolar lavage will be collected.; Diagnostic test: blood draw; As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of eosinophils in untreated non-small cell lung cancer patients	Concentration of eosinophils will be used in various bodily materials as described above.	Baseline (pre-treatment)

Secondary Outcome Measures

Outcome Measure	Time Frame
Prognostic and predictive value of eosinophils in non-small cell lung cancer patients	Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Leukocyte Disorders; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Eosinophilia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 2022/258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No