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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Integro Theranostics
Study ID
NCT07276789
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LS301-IT 0.1 mg/kg — DRUG
    Single dose of LS301-IT administed up to 4 days prior to surgery

Study Details

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).

Key Dates

Start date
Dec 8, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: LS301-IT 1.0 mg/kg

Primary Outcome Measure

Clinically Significant Events [ Time Frame: On the day of surgery ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Jim Joffrion
[email protected]
314-779-9620
University of Texas Southwestern Medical CenterDallasTexas75390
Jim Joffrion
[email protected]
3147799620

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By research site
University of Pennsylvania· Philadelphia, PAUniversity of Texas Southwestern Medical Center· Dallas, TX

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