ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting (Elucidate)

On Target Laboratories

Status and phase: Completed; Phase 3

Conditions: Lung Neoplasms; Lung Cancer

Treatments: Drug: OTL38 for Injection; Device: Near infrared camera imaging system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04241315

OTL-2019-OTL38-007

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and Female subjects 18 years of age and older
2. Have a primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging
3. Are scheduled to undergo surgical thoracoscopy for diagnostic wedge resection followed by anatomic lung resection
4. 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
5. 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

1. Previous exposure to OTL38
2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
3. 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.
4. History of allergy to any of the components of OTL38, including folic acid
5. 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
6. Clinically significant abnormalities on electrocardiogram (ECG) at screening.
7. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol and follow-up schedule
8. Impaired renal function defined as eGFR< 50 mL/min/1.73m2
9. 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.
10. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of study drug
11. Known sensitivity to fluorescent light

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Near-Infrared Imaging group

Experimental group

Description:

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

Treatment:

Device: Near infrared camera imaging system

Drug: OTL38 for Injection

No Imaging Group

Other group

Description:

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

Treatment:

Drug: OTL38 for Injection