Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LS301-IT 0.1 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LS301-IT 1.0 mg/kg
- interventionNames
- Drug: LS301-IT 0.1 mg/kg
Primary outcomes (1)
- measure
- Clinically Significant Events
- timeFrame
- On the day of surgery
- description
- 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)
Secondary outcomes (6)
- measure
- Sensitivity
- timeFrame
- day or surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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