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.

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.

As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.

As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

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