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
Condition(s) studied
Investigational drug(s) / intervention(s)
LS301-IT 0.1 mg/kg: Single dose of LS301-IT administed up to 4 days prior to surgery
Study summary
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).
Eligibility
Primary outcome measure(s)
- Clinically Significant Events — On the day of surgery
To determine the proportion of subjects that have at least one CSE where a CSE is defined as one of 3 possible clinical events: a. Identification of primary tumor in situ with fluorescence IMI after non-ID with white light b. Identification of synchronous or occult lung tumors with fluorescence IMI after non-ID with white light c. Identification of tumor margin of resected specimen ex vivo within 10 mm of staple line with fluorescence IMI (both ≤5 mm and ≤10 mm will be assessed)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07276789 on ClinicalTrials.gov ↗ ← All trials in the USA