🔎 Trials Near Me

Home › Non-Small Cell Lung Cancer › NCT07276789

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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the 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).

What is being tested

Sponsor: Integro Theranostics · Participants: 35 · Started: Dec 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07276789

Locations in the U.S.

PennsylvaniaUniversity of Pennsylvania, Philadelphia
TexasUniversity of Texas Southwestern Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.