Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)

NCT06193239 | Recruiting Phase 2

• 1 other identifier: OML-EV2-1.0
• Study Type: interventional
• Target: 350
• Locations: 3 countries
• Sites: 9

Brief Summary

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups. The contrast groups will be representative of the clinical populations in which the test is intended to be used. Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.

Conditions

Lung Cancer

Keywords

Lung Cancer; Diagnostic Test; Diagnostic Breath test

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The primary endpoint is to assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test to differentiate between individuals with lung cancer and contrast groups. This will be reported using a Receiver Operator Characteristic Curve, NPV, PPV, Sensitivity, Specificity \& Likelihood Ratio's. Metrics will be reported for overall test performance as well as pre-defined subgroup analyses.

  12 months

Secondary Outcomes (2)

• Optimised test

  12 months

• Safety and tolerability

  12 months

Study Arms (1)

OWL-EVO1

EXPERIMENTAL

After confirming full eligibility, individuals will all be administered the OWL-EVO1 probe intravenously. This includes: * Patients diagnosed with histopathologically confirmed lung cancer. * Individuals with a CT-proven absence of lung cancer, including those with relevant comorbidities and risk factors such as smoking, COPD, asthma, extrapulmonary malignant tumours, active lung infection/inflammation and other chronic respiratory diseases.

Diagnostic Test: OWL-EVO1

Interventions

OWL-EVO1 DIAGNOSTIC_TEST

EVOC probe

Also known as: OWL-EVO1 Breath Biopsy Test, D5-ethyl-βD-glucuronide

OWL-EVO1

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 45-85 years.
• Ability to provide informed consent.
• BMI 16 - \<40.
• Receiving a CT including the thoracic region, within the last 6 months.

You may not qualify if:

• (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
• Potential subjects who in the opinion of the investigator lack mental capacity.
• Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer.\*
• Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis\*\*.
• Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment.
• Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures.
• Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods (Subjects must agree to use contraception for 2 months post last dose).
• Individuals under investigation for suspicion of lung cancer who are unlikely to receive a definitive tissue diagnosis of lung cancer prior to treatment (e.g. stereotactic ablative radiotherapy without tissue confirmation).
• Note:
• In the case that the participant has taken part in a study with an investigational medicinal product please contact the Owlstone medical monitor for advice.
• \*\*Note: Individuals with a confirmed cancer diagnosis ARE eligible (such as a diagnosis of prostate cancer now undergoing hormone therapy). Individual with a previous history of cancer other than lung cancer, including those under active surveillance, ARE eligible. Individuals scheduled to attend a cancer screening program; prostate, breast, lung, colon, ARE eligible.

Sponsors & Collaborators

• Owlstone Ltd: lead

Study Sites (9)

Thomayer Hospital

Prague, Prague, 140 59, Czechia

RECRUITING

National Koranyi Institute for Pulmonology

Budapest, Budapest, H-1121, Hungary

NOT YET RECRUITING

Department of Pulmonology, University of Debrecen

Debrecen, Debrecen, H-4032, Hungary

RECRUITING

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

RECRUITING

Wythenshawe Hospital

Manchester, Greater Manchester, M23 9LT, United Kingdom

RECRUITING

Glenfield Hospital

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

Barts Health NHS Trust

London, London, E1 1FR, United Kingdom

NOT YET RECRUITING

Imperial Centre for Translational and Experimental Medicine, Imperial College

London, London, W12 0HS, United Kingdom

RECRUITING

Quadram Institute

Norwich, Norfolk, NR4 7UQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Rintoul

  Royal Papworth Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Thompson

CONTACT

01223 428200; EDLC@owlstone.co.uk

Alice Michael

CONTACT

01223 428200; EDLC@owlstone.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with and without suspicion of having lung cancer will all receive the same IMP

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: October 5, 2023
• Primary Completion: April 25, 2025
• Study Completion: April 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6); HU (2); CZ (1)