Non-small Cell Lung CancerPROTEONNCT05602259
PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
A study testing induced sputum, lung biopsy and bronchoalveolar lavage in people with Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- induced sputum, lung biopsy and bronchoalveolar lavage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Oct 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
Anne Sibille, MD, +3243237400, anne.sibille@chuliege.be
Aurore Cue Alvarez, +3243235539, aurore.cuealvarez@chuliege.be
About this study
Official title: 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- induced sputum, lung biopsy, bronchoalveolar lavage, blood draw
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induced sputumDiagnostic test
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 biopsyDiagnostic test
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
bronchoalveolar lavageDiagnostic test
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
blood drawDiagnostic test
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Eosinophil detection | Experimental | Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies. Receives: Diagnostic Test: induced sputum; Diagnostic Test: lung biopsy; Diagnostic Test: bronchoalveolar lavage; Diagnostic Test: blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of eosinophils in untreated non-small cell lung cancer patients
Concentration of eosinophils will be used in various bodily materials as described above.
Measured: Baseline (pre-treatment)
Secondary outcomes (1)
Prognostic and predictive value of eosinophils in non-small cell lung cancer patients
Measured: Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start27 Oct 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Sibille, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602259
- Sponsor's protocol ID
- 2022/258
- Acronym
- PROTEON
- Status last verified
- Feb 2024
- First submitted
- 27 Oct 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).
- ClinicalTrials.gov ID
- NCT05602259
- Acronym / sponsor ID
- PROTEON / 2022/258
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eosinophil detection | Experimental | Diagnostic Test: induced sputum, Diagnostic Test: lung biopsy, Diagnostic Test: bronchoalveolar lavage, Diagnostic Test: blood drawEosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- o All stages of NSCLC
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| induced sputumAfter 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 | Eosinophil detection |
| lung biopsyAs per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site. | Diagnostic test | Eosinophil detection |
| bronchoalveolar lavageWhen available, the remaining material from a patient's bronchoalveolar lavage will be collected. | Diagnostic test | Eosinophil detection |
| blood drawAs per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected. | Diagnostic test | Eosinophil detection |
Primary outcome
Detection of eosinophils in untreated non-small cell lung cancer patients
Time frame: Baseline (pre-treatment)
Concentration of eosinophils will be used in various bodily materials as described above.
1 secondary outcome
Prognostic and predictive value of eosinophils in non-small cell lung cancer patients
Time frame: Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing induced sputum, lung biopsy and bronchoalveolar lavage in people with Non-small Cell Lung Cancer, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Sibille, MD (+3243237452, anne.sibille@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of eosinophils in untreated non-small cell lung cancer patients (time frame: Baseline (pre-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.