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
About this 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).
- Condition
- Non Small Cell Lung Cancer (NSCLC)
- Tested
- LS301-IT 0.1 mg/kg
- Sponsor
- Integro Theranostics
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Non Small Cell Lung Cancer (NSCLC)
- 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 8
- 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
Where
2 sites, 2 recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Contact
-
Jim Joffrion
314-779-9620 jjoffrion@integrotheranostics.com
Potential match only. Final eligibility is determined by the study team.