Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

LS301-IT 0.1 mg/kg

Single dose of LS301-IT administed up to 4 days prior to surgery

Locations (1)

University of Pennsylvania
Philadelphia, Pennsylvania, United States