Single IV dose of LS301-IT to make lung tumors glow during minimally invasive surgery for early-stage NSCLC.
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
We will test whether a single IV dose of LS301-IT helps surgeons see and remove tumors during VATS or RATS in people with Stage I–II non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Integro Theranostics Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT07276789 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study gives a single intravenous dose of LS301-IT, a fluorescent imaging agent, to patients undergoing VATS or RATS resection for Stage I–II non-small cell lung cancer. Intraoperative fluorescence imaging will be used to identify primary tumors that white light may miss, detect synchronous or occult pulmonary lesions, and reveal inadequate surgical margins. The primary outcome is the proportion of patients with at least one clinically significant event identified by fluorescence; secondary outcomes include sensitivity and positive predictive value versus histopathology and safety/tolerability. Exploratory objectives include measuring how often fluorescence changes the surgical plan, optimizing the dosing interval before surgery, and standardizing intraoperative imaging and surgeon fluorescence assessment.
Who should consider this trial
Good fit: Adults with biopsy-proven or highly suspected Stage I–II NSCLC who are scheduled for VATS or RATS lung resection, have adequate renal function, and no history of severe contrast or drug hypersensitivity are the ideal candidates.
Not a fit: Patients with impaired renal function, a history of anaphylactic reactions to contrast agents, significant ECG abnormalities, or those not undergoing minimally invasive resection are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, LS301-IT could help surgeons find hidden tumors and confirm clear margins during minimally invasive lung cancer surgery, potentially reducing missed disease and reoperations.
How similar studies have performed: Fluorescence-guided surgery with agents like indocyanine green and other tumor-targeted dyes has shown promise in locating tumors in several cancers, but LS301-IT is a novel agent and its effectiveness for lung cancer resection is still being determined in this Phase 2 trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jim Joffrion
- Email: jjoffrion@integrotheranostics.com
- Phone: 314-779-9620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.