Non Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
lung cancer, lung cancer resection, Non Small Cell Lung Cancer Resection, Non-Small Cell Lung Cancer Stage I-II
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).
Detailed description
The primary objective of the study is to determine the proportion of subjects that have at least one Clinically Significant Event (CSE) using fluorescence imaging, defined as either the localization of the primary tumor when white light has failed to identify the tumor, the identification of a synchronous or occult pulmonary tumor with fluorescence only, or the identification of an inadequate surgical margin after resection. Secondary objectives include the determination of the sensitivity and positive predictive value (PPV) of LS301 fluorescence imaging in the identification of tumor using histopathology as the gold standard, and the assessment of the safety and tolerability of LS301-IT. Exploratory objectives include the determination of the "Clinical Impact Rate" defined as the proportion of cases when the surgeon changes the scope of the procedure based on LS301 fluorescence imaging, the assessment of the dosing interval prior to surgery, and the standardization of imaging during surgery and surgeon assessment of fluorescence.
Interventions
Single dose of LS301-IT administed up to 4 days prior to surgery
Sponsors
Integro Theranostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Pathologist
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Events | On the day of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | day or surgery | The number of patients that are true positive divided by the number of patients that are true positive + the number of patients that are false positive (True Positive/True Positive + False Negative) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard |
| Positive Predictive Value | day of surgery | Number of patients that are true positive divided by the number of patients that are true positive + false positive (True Positive/(True Positive + False Positive) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard |
| Primary tumor identification rate | day of surgery | Proportion of patients that underwent flourescent imaging where the primary tumor was identified by flourescence |
| Synchronous or occult tumor identification rate | day of surgery | Propotion of the total number of synchronous or occult tumors identified by flourescent imaging |
| Close margin rate | day of surgery | The proportion of patients with a close margin identified by fluorescent imaging. Close margin is defined as a margin within less than or equal to 5 mm from the staple line and less than or equal to 10 mm from the staple line |
| Incidence of Adverse Events | within 30 days after dosing | The proportion of patients reporting at least one adverse event |
Countries
United States
Contacts
CONTACTJim Joffrion
STUDY_DIRECTORRobert Honigberg, MD
Integro Theranostics
Outcome results
None listed