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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: induced sputum
* Diagnostic Test: lung biopsy
* Diagnostic Test: bronchoalveolar lavage
* Diagnostic Test: blood draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eosinophil detection<br>Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies. | Diagnostic Test: induced sputum<br>* 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.<br>Diagnostic Test: lung biopsy<br>* As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.<br>Diagnostic Test: bronchoalveolar lavage<br>* When available, the remaining material from a patient's bronchoalveolar lavage will be collected.<br>Diagnostic Test: blood draw<br>* As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.<br>|

What is the study measuring?
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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 | Measure Description | 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 |