Recruiting
Phase 2

LS301-IT

Sponsor:

Integro Theranostics

Code:

NCT07276789

Conditions

Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LS301-IT 0.1 mg/kg

Study Details

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).

Conditions

Non Small Cell Lung Cancer (NSCLC)

Study ID

NCT07276789

Start date

Dec 8, 2025

Status verified date

Apr, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: LS301-IT 1.0 mg/kg

Interventions

LS301-IT 0.1 mg/kg

Single dose of LS301-IT administed up to 4 days prior to surgery

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jim Joffrion

314-779-9620jjoffrion@integrotheranostics.com

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Jim Joffrion

314-779-9620jjoffrion@integrotheranostics.com

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Jim Joffrion

3147799620jjoffrion@integrotheranostics.com

More Information

Sponsor

Integro Theranostics

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • lung cancer
  • lung cancer resection
  • Non Small Cell Lung Cancer Resection
  • Non-Small Cell Lung Cancer Stage I-II

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Integro Theranostics on 2026-04-20.