ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

NCT04241315 | Completed Phase 3 Results FDA Drug FDA Device

• 1 other identifier: OTL-2019-OTL38-007
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 12

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.

Conditions

Lung Neoplasms; Lung Cancer

Keywords

Intraoperative Imaging

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Sensitivity for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects

  1 day

• False Positive Rate for Cancerous Primary Nodules and Synchronous Lesions in FAS Subjects

  1 day

Study Arms (2)

Near-Infrared Imaging group

EXPERIMENTAL

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

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

No Imaging Group

OTHER

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

Drug: OTL38 for Injection

Interventions

OTL38 for Injection DRUG

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Also known as: CYTALUX™ (pafolacianine) injection

Near-Infrared Imaging group; No Imaging Group

Near infrared camera imaging system DEVICE

Near infrared camera imaging system

Near-Infrared Imaging group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• On Target Laboratories, LLC: lead
• Clinipace Worldwide: collaborator

Study Sites (12)

Stamford

Stamford, Connecticut, 06904, United States

Location

University of Iowa

Iowa City, Iowa, 55242, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Hospital

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Pafolacianine; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Tommy Lee
• Organization: On Target Laboratories, Inc.

tlee@ontargetlabs.com

214-289-6422

Study Officials

• Sunil Singhal, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: March 26, 2020
• Primary Completion: October 7, 2021
• Study Completion: November 1, 2021
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)