RecruitingPhase 2NCT07276789

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


Sponsor

Integro Theranostics

Enrollment

35 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a fluorescent dye called LS301-IT given before lung surgery to help surgeons see cancer tissue more clearly in real time during the operation. The goal is to make lung cancer surgery more precise. **You may be eligible if...** - You have been diagnosed with (or are strongly suspected to have) lung cancer - You are already scheduled for thoracoscopic (keyhole) lung surgery and tumor removal - Your kidneys and liver are functioning adequately - If you are of childbearing potential, you have a negative pregnancy test **You may NOT be eligible if...** - You have a medical condition that makes surgery unsafe - You have had allergic reactions to contrast dyes (like indocyanine green) or similar agents - You have impaired kidney function - You have had radiation therapy to the chest - Your liver enzymes or bilirubin levels are elevated above certain thresholds - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLS301-IT 0.1 mg/kg

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


Locations(2)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT07276789


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