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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
A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- LS301-IT 0.1 mg/kg (drug)
Sponsor: Integro Theranostics · Participants: 35 · Started: Dec 8, 2025
Contact the study team
- Jim Joffrion · Phone: 314-779-9620
Official record on ClinicalTrials.gov — NCT07276789
Locations in the U.S.
| Pennsylvania | University of Pennsylvania, Philadelphia |
| Texas | University of Texas Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.