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

NCT07276789 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LS301-IT-B201
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Non Small Cell Lung Cancer (NSCLC)

Keywords

lung cancer; lung cancer resection; Non Small Cell Lung Cancer Resection; Non-Small Cell Lung Cancer Stage I-II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sensitivity

  day or surgery

• Positive Predictive Value

  day of surgery

• Primary tumor identification rate

  day of surgery

• Synchronous or occult tumor identification rate

  day of surgery

• Close margin rate

  day of surgery

Study Arms (1)

LS301-IT 1.0 mg/kg

EXPERIMENTAL

Drug: LS301-IT 0.1 mg/kg

Interventions

LS301-IT 0.1 mg/kg DRUG

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

LS301-IT 1.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integro Theranostics: lead

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Honigberg, MD

  Integro Theranostics

  STUDY DIRECTOR

Central Study Contacts

Jim Joffrion

CONTACT

314-779-9620; jjoffrion@integrotheranostics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Pathologist
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-dose, open-label, multicenter, Phase 2 study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS or RATS). Single dose IV infusion of 0.1 mg/kg of LS301-IT given up to 4 days before surgery. There will be no stratification by dosing interval, type of minimally invasive surgery, or tumor type.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)