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

• ClinicalTrials.gov Identifier: NCT04241315
• Recruitment Status: Completed
• First Posted: January 27, 2020
• Last Update Posted: February 16, 2022
• Sponsor: On Target Laboratories, LLC
• Collaborator: Clinipace Worldwide
• Information provided by (Responsible Party): On Target Laboratories, LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lung Neoplasms; Lung Cancer	Drug: OTL38 for Injection; Device: Near infrared camera imaging system	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
• Actual Study Start Date: March 26, 2020
• Actual Primary Completion Date: October 7, 2021
• Actual Study Completion Date: November 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Near-Infrared Imaging group; All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.	Drug: OTL38 for Injection; Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL; Other Name: CYTALUX™ (pafolacianine) injection; Device: Near infrared camera imaging system; Near infrared camera imaging system
No Imaging Group; All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.	Drug: OTL38 for Injection; Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL; Other Name: CYTALUX™ (pafolacianine) injection

Outcome Measures

Primary Outcome Measures :

1. Clinically Significant Events (CSE) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Stamford

Stamford, Connecticut, United States, 06904

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 55242

United States, Massachusetts

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22908

United States, Washington

Swedish Hospital

Seattle, Washington, United States, 98109

Sponsors and Collaborators

On Target Laboratories, LLC

Clinipace Worldwide

Investigators

• Principal Investigator: Sunil Singhal, MD; University of Pennsylvania

More Information

• Responsible Party: On Target Laboratories, LLC
• ClinicalTrials.gov Identifier: NCT04241315
• Other Study ID Numbers: OTL-2019-OTL38-007
• First Posted: January 27, 2020
• Last Update Posted: February 16, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by On Target Laboratories, LLC:

Intraoperative Imaging

Additional relevant MeSH terms:

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