Phase 2
N=100
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Lung Neoplasms · Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02872701 ↗Enrolled (actual)
100
Serious AEs
14.0%
Results posted
Mar 2023
Primary outcome: Primary: Sensitivity or True Positive Rate (TPR) — 0.854 proportion of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OTL38 for Injection (Drug); Near infrared camera imaging system (Device); Endoscopic or Thoracic Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- On Target Laboratories, LLC
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity or True Positive Rate (TPR) |
0.854 | — |
| PRIMARY False Positive Rate (FPR) |
0.138 | — |
| SECONDARY Proportion of Patients With at Least 1 Clinically Significant Event (CSE) |
0.293 | — |
| SECONDARY Positive Margin Identification |
8 | — |
| SECONDARY Synchronous Lesion Identification |
7 | — |
| SECONDARY Pulmonary Nodule Identification |
10 | — |
Summary
This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography 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.
Eligibility Criteria
Inclusion Criteria
- Male and Female patients 18 years of age and older
- Confirmed diagnosis of adenocarcinoma lung cancer OR,
- Have a primary diagnosis, or at high clinical suspicion, of lung nodule(s) warranting surgery based on CT and/or PET imaging
- Who are scheduled to undergo endoscopic or thoracic surgery surgery
- A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
- Female patients 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
- Known Folate Receptor-negative lung nodules
- Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
- History of anaphylactic reactions or severe allergies
- History of allergy to any of the components of OTL38, including folic acid
- Pregnancy, or positive pregnancy test
- Clinically significant abnormalities on electrocardiogram (ECG) at screening.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Impaired renal function defined as epidermal growth factor receptor (eGFR) 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
- Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
- Known sensitivity to fluorescent light
Data sourced from ClinicalTrials.gov (NCT02872701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.