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

Non-small Cell Lung Cancer Clinical Trial

— PROTEON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602259
• Other study ID #: 2022/258
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Anne Sibille, MD
• Phone: +3243237452
• Email: anne.sibille[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Eosinophilia
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.
• lung biopsy
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
• bronchoalveolar lavage
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
• blood draw
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prognostic and predictive value of eosinophils in non-small cell lung cancer patients		Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment