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

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).

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: LS301-IT 0.1 mg/kg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jim Joffrion; Phone Number: 314-779-9620; Email: jjoffrion@integrotheranostics.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Jim Joffrion; Phone Number: 314-779-9620; Email: jjoffrion@integrotheranostics.com
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Jim Joffrion; Phone Number: 3147799620; Email: jjoffrion@integrotheranostics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LS301-IT 1.0 mg/kg	Drug: LS301-IT 0.1 mg/kg; Single dose of LS301-IT administed up to 4 days prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically Significant Events	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)	On the day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The number of patients that are true positive divided by the number of patients that are true positive + the number of patients that are false positive (True Positive/True Positive + False Negative) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard	day or surgery
Positive Predictive Value	Number of patients that are true positive divided by the number of patients that are true positive + false positive (True Positive/(True Positive + False Positive) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard	day of surgery
Primary tumor identification rate	Proportion of patients that underwent flourescent imaging where the primary tumor was identified by flourescence	day of surgery
Synchronous or occult tumor identification rate	Propotion of the total number of synchronous or occult tumors identified by flourescent imaging	day of surgery
Close margin rate	The proportion of patients with a close margin identified by fluorescent imaging. Close margin is defined as a margin within less than or equal to 5 mm from the staple line and less than or equal to 10 mm from the staple line	day of surgery
Incidence of Adverse Events	The proportion of patients reporting at least one adverse event	within 30 days after dosing

Collaborators and Investigators

• Sponsor: Integro Theranostics
• Investigators: Study Director: Robert Honigberg, MD, Integro Theranostics

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer; lung cancer resection; Non Small Cell Lung Cancer Resection; Non-Small Cell Lung Cancer Stage I-II
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LS301-IT-B201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the study is an early stage study, there is no current plan to share the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No