ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

Lung Cancer Clinical Trial

— Elucidate  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241315
• Other study ID #: OTL-2019-OTL38-007
• Status: Completed
• Phase: Phase 3
• Start date: March 26, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: January 2023
• Source: On Target Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 1, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Device:
• Near infrared camera imaging system
Near infrared camera imaging system

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
On Target Laboratories, LLC	Clinipace Worldwide

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically Significant Events (CSE)	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.	1 day
Primary	Localization of Primary Nodule	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	1 day
Primary	Identification of Cancerous Synchronous Lesions	The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation	1 day
Primary	Positive Resection Margins	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	1 day
Secondary	Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	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.	1 day
Secondary	False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects	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	1 day