Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Owlstone Medical Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Nov 2023 → ongoing

Decision date (initial)

2023-11-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

Diagnostic accuracy: To assess diagnostic accuracy of the OWL-EVO1 Breath Biopsy test (OBBT) to differentiate between individuals with relevant clinical presentations in which the test is intended to be used (lung cancer and contrast groups representing clinical presentation that include lung cancer as part of its differential diagnosis).

In this context relevant clinical presentations means:

Individuals eligible for lung cancer screening based on low dose CT with or without lung cancer.

Incidental findings on CT-scan suspicious of lung cancer

Clinical presentations which include lung cancer as part of their differential diagnosis

Secondary objectives 2

1. Optimised test: The optimal OWL-EVO1 test maximises the difference between the breath signal of individuals with and without lung cancer. The magnitude of the breath signal is a function of the pharmacokinetics (and therefore dose of OWL-EVO1), the breath sampling time point, and its duration. This secondary objective will identify optimal testing parameters (dose, time point, and breath sampling duration) that maximise diagnostic accuracy and tolerability whilst minimising healthcare worker effort. The approach to this optimisation is specified in Section 5.5 of the Protocol.
2. Safety and tolerability of OWL-EVO1

Conditions and MedDRA coding

Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 9

1. (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
2. Potential subjects if in the opinion of the investigator lack mental capacity
3. 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
4. Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis
5. Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment
6. 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
7. 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)
8. 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)
9. Further to the above stated exclusion criteria, in the interest of subject safety, exclusion of any subject is at the ultimate discretion of the investigator. This includes (but is not limited to) subjects who are acutely unwell according to investigator assessment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Diagnostic accuracy: Diagnostic accuracy will be reported using a Receiver Operator Characteristic (ROC) curve and Area Under the Curve (AUC), as well as negative predictive value (NPV), positive predictive value (PPV), Sensitivity and Specificity. Metrics will be reported for overall test performance at all timepoints as well as pre-defined subgroup analyses.

Secondary endpoints 2

1. Optimised test: Locked down protocol for breath sampling through evaluation of method, sampling timepoints, posture and duration of breath samples and determination of OWL-EVO1 dose. This optimised test will then be used to assess the primary objective.
2. Safety and tolerability: Refined understanding of safety and tolerability of OWL-EVO1 based on reported Adverse Events associated with probe administration

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Owlstone Medical Limited

Sponsor organisation

Owlstone Medical Limited

Address

183 Science Park, Milton Road Milton Road

City

Cambridge

Postcode

CB4 0GJ

Country

United Kingdom

Scientific contact point

Organisation

Owlstone Medical Limited

Contact name

Senior Translational Scientist

Public contact point

Organisation

Owlstone Medical Limited

Contact name

Senior Translational Scientist

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications