UPCC 16525 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

Investigational Imaging for Lung Cancer Surgery

Enrolling By Invitation
18 years or above
All
Phase 2
35 participants needed
1 Location

Brief description of 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).

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non Small Cell Lung Cancer (NSCLC)
  • Age: 18 years or above
  • Gender: All

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

This study investigates the use of an investigational imaging agent for lung cancer surgery. The purpose of this study is to explore the effectiveness and safety of a single dose of a fluorescence imaging agent administered through intravenous infusion. This agent is used during surgical procedures for patients with Stage I-II non-small cell lung cancer (NSCLC) to help locate tumors that might not be visible with standard white light imaging.

Participants will receive the imaging agent before undergoing Video-Assisted Thoracoscopic Surgery (VATS) or Robotic-Assisted Thoracoscopic Surgery (RATS). The study will evaluate how well the imaging agent helps in identifying tumors and ensuring complete tumor removal. The safety and tolerability of the imaging agent will also be assessed.

  • Who can participate: Adults with a primary diagnosis or high suspicion of lung cancer based on imaging tests are eligible. Participants must be scheduled for lung surgery and, if of childbearing potential, must have a negative pregnancy test and use contraception. Key exclusions include contraindications for surgery, drug allergies, impaired renal function, and recent chest radiation.
  • Study details: Participants will receive an investigational imaging agent through an IV infusion before surgery. This agent helps surgeons see tumors more clearly during the operation. The study will assess how well this imaging method works and its safety for patients.
Updated on 20 Apr 2026. Study ID: 25-1601
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