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Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer
Trial Status: active
The aim of this Phase 2 study is to investigate the efficacy and safety of a single dose
of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT),
administered by intravenous (IV) infusion in patients undergoing VATS (Video-Assisted
Thoracoscopic Surgery) or RATS (Robotic-Assisted Thoracoscopic Surgery) resection of
Stage I-II non-small cell lung cancer (NSCLC).
Inclusion Criteria
Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
Are scheduled to undergo surgical thoracoscopy and resection of the lung.
If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to LS301-IT administration, as well as using a medically acceptable form of contraception (eg, hormonal birth control, double-barrier method) or abstinence.
Ability to understand the requirements of the study
Exclusion Criteria
Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other contrast agents.
Patients with impaired renal function
History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities
History of radiation therapy to the chest
Total bilirubin level >1.5 times upper limit
Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN)
Patient is pregnant or breast feeding
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07276789.
Locations matching your search criteria
United States
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Approved
Name Not Available
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not Available
The primary objective of the study is to determine the proportion of subjects that have
at least one Clinically Significant Event (CSE) using fluorescence imaging, defined as
either the localization of the primary tumor when white light has failed to identify the
tumor, the identification of a synchronous or occult pulmonary tumor with fluorescence
only, or the identification of an inadequate surgical margin after resection. Secondary
objectives include the determination of the sensitivity and positive predictive value
(PPV) of LS301 fluorescence imaging in the identification of tumor using histopathology
as the gold standard, and the assessment of the safety and tolerability of LS301-IT.
Exploratory objectives include the determination of the "Clinical Impact Rate" defined as
the proportion of cases when the surgeon changes the scope of the procedure based on
LS301 fluorescence imaging, the assessment of the dosing interval prior to surgery, and
the standardization of imaging during surgery and surgeon assessment of fluorescence.
