Back to search results

LS301-IT for Lung Cancer Surgery

This study is testing a new imaging agent called LS301-IT to see how well it helps surgeons find non-small cell lung cancer (NSCLC) during surgery. You might be able to join if you are an adult with suspected or diagnosed lung cancer and are scheduled for lung surgery. The study aims to see if LS301-IT helps surgeons find tumors that are hard to see with regular light, or if it helps them make sure all the cancer is removed. The study is also looking at the safety of LS301-IT. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 35 participants. It is a single-arm study, meaning all participants will receive the LS301-IT intervention.
What's involved
You would receive a single dose of LS301-IT up to 4 days before your surgery. If you can become pregnant, you will need to have negative pregnancy tests.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Clinically Significant Events, is measured on the day of surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276789

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Integro Theranostics
~35 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:LS301-IT 0.1 mg/kg

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinically Significant Events
Measured over On the day of surgery

Conditions

Non Small Cell Lung Cancer (NSCLC)

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

2 sites across 2 states
Pennsylvania1
Texas1

Study leadership

  • Robert Honigberg, MD · STUDY_DIRECTOR · Integro Theranostics

Who to contact

Jim Joffrion
[email protected]
314-779-9620
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Clinically Significant EventsOn 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)