ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

Phase 3

Completed

Interventions: Drug: OTL38 for Injection
Device: Near infrared camera imaging system

Brief Summary: This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

Recruitment & Eligibility

Inclusion Criteria

Male and Female subjects 18 years of age and older
Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
Female subjects of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria

Previous exposure to OTL38
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
History of anaphylactic reactions to folate, including synthetic folic acid (pteroylmonoglutamic acid) and contrast agents containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
History of allergy to any of the components of OTL38, including folic acid
A positive serum pregnancy test at Screening or a positive urine pregnancy test on the day of surgery or day of admission for female subjects of childbearing potential
Clinically significant abnormalities on electrocardiogram (ECG) at screening.
Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as eGFR< 50 mL/min/1.73m2
Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >2x ULN for total bilirubin except in subjects with Gilbert's syndrome.
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
Known sensitivity to fluorescent light

Arm && Interventions

Group	Intervention	Description
Near-Infrared Imaging group	OTL38 for Injection	All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
Near-Infrared Imaging group	Near infrared camera imaging system	All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
No Imaging Group	OTL38 for Injection	All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

Primary Outcome Measures

Name	Time	Method
Clinically Significant Events (CSE)	1 day	The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.
Localization of Primary Nodule	1 day	Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation
Identification of Cancerous Synchronous Lesions	1 day	The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation
Positive Resection Margins	1 day	The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

Secondary Outcome Measures

Name	Time	Method
Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	1 day	Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.
False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	1 day	False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Locations (12): University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Stamford
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Stamford, Connecticut, United States
University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States
Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
Cleveland Clinic
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Cleveland, Ohio, United States
Mayo Clinic
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Rochester, Minnesota, United States
MD Anderson Cancer Center
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Houston, Texas, United States
Swedish Hospital
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Seattle, Washington, United States
University of Virginia
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Charlottesville, Virginia, United States
University of Iowa
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Iowa City, Iowa, United States
University of Michigan
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Ann Arbor, Michigan, United States