A Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies in Patients Undergoing Routine Surgery

Study Overview
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Brief Summary
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This Phase 2 study is an open-label, single-arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.

Official Title
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A Phase 2, Single-Dose, Open-Label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies, in Patients Undergoing Routine Surgery

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: pegsitacianine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging Exclusion Criteria: Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG) Tumor locations the surgeon deems unfeasible to image intraoperatively Excessive and/or generalized disease deemed inoperable by the surgeon Life expectancy less than 12 weeks

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
Interventional Model Description: An interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care (SOC) surgery.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence imaging with pegsitacianine<br>Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. | Drug: pegsitacianine<br>* An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).<br>* Other names: ONM-100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Patients experiencing at least one Clinically Significant Event (CSE) | Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Severity of adverse events related to Pegsitacianine | Treatment emergent adverse events | 30 days | 
| Pegsitacianine fluorescence and imaging performance | Sensitivity, specificity, negative and positive predictive values of the imaging agent at the level of the individual patient specimens will be calculated | 7 days |