35 Participants Needed

LS301-IT for Lung Cancer

JJ
Overseen ByJim Joffrion
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Integro Theranostics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, LS301-IT, to evaluate its effectiveness and safety for people with early-stage lung cancer. Participants will receive a dose of this agent before specific lung surgeries. The trial targets individuals with confirmed or highly suspected lung cancer who are scheduled for surgery. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that LS301-IT is likely to be safe for humans?

Research has shown that LS301-IT, a new imaging agent used during lung cancer surgery, has been safe in earlier studies. In past research, LS301-IT was tested on patients, and the results were positive. Patients handled the treatment well, and no serious side effects occurred. This imaging agent works by directly targeting cancer cells, helping surgeons see and remove tumors more effectively. Since the current study is in Phase 2, LS301-IT has already demonstrated some safety in earlier trials. While every treatment carries potential risks, previous data suggest that LS301-IT is generally well-tolerated in people.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about LS301-IT for lung cancer because it introduces a novel mechanism of action compared to standard treatments like chemotherapy and targeted therapies. Unlike these options, LS301-IT is designed to be administered directly into the tumor, potentially enhancing its ability to attack and shrink the cancer cells more effectively. This targeted delivery method may result in fewer side effects and a more efficient response in combating the tumor, offering hope for improved outcomes in lung cancer treatment.

What evidence suggests that LS301-IT might be an effective treatment for lung cancer?

Research has shown that LS301-IT, the treatment under study in this trial, is a promising option for lung cancer. In earlier studies, LS301-IT helped surgeons see cancerous tissues more clearly during surgery. This special imaging agent makes tumors glow, aiding doctors in removing them more accurately. Initial findings also showed that LS301-IT is safe to use, with no major safety concerns reported. While researchers continue to collect more data, these early results suggest that LS301-IT could improve surgery outcomes for patients with non-small cell lung cancer.34678

Who Is on the Research Team?

RH

Robert Honigberg, MD

Principal Investigator

Integro Theranostics

Are You a Good Fit for This Trial?

This trial is for individuals with Stage I-II non-small cell lung cancer (NSCLC) who are scheduled for surgical removal of the cancer using thoracoscopy and VATS or RATS techniques. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am diagnosed or suspected to have lung cancer based on scans or biopsy.
I am scheduled for lung surgery via a small chest incision.
I am not pregnant and will use birth control or abstain from sex during the trial.
See 1 more

Exclusion Criteria

History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities
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)
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LS301-IT administered by intravenous infusion for fluorescence imaging during lung cancer resection surgery

1 day
1 visit (in-person, day of surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the incidence of adverse events

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • LS301-IT

Trial Overview

The study tests a single dose of LS301-IT, an imaging agent given through IV to help surgeons see cancerous tissue during minimally invasive lung surgery. The goal is to assess how well it works and its safety.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LS301-IT 1.0 mg/kgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Integro Theranostics

Lead Sponsor

Trials
2
Recruited
120+

Citations

NCT07276789 | Phase 2, Open-Label, Multicenter Study to ...

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 ...

Promising Phase 1b Lung Cancer Surgery Clinical Trial ...

Results indicate safety and preliminary efficacy of LS301 for intraoperative cancer visualization. SAINT LOUIS, MO, UNITED STATES, September ...

Study Details | NCT06713564 | A Single Dose, Open-Label ...

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed ...

Integro Theranostics announces positive Phase 1b clinical ...

Lung cancer surgery study results for proprietary tumor-targeting agent, CXL (formerly known as LS301), shows promising preliminary safety ...

LS301-IT Imaging for Lung Cancer · Info for Participants

Trial Overview The study tests LS301-IT, a new imaging agent given by IV before surgery. It's designed to help surgeons see the cancer better during operation.

Study Details | NCT06713564 | A Single Dose, Open-Label ...

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed ...

A Single Dose, Open-Label, Dose-escalation Study of the ...

The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging ...

8.

integrotheranostics.com

integrotheranostics.com/science

Science

LS301 is a stable molecule that directly targets cancer cells. It selectively binds to an activated protein that is uniquely expressed by cancer cells.