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NCT07276789 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Integro Theranostics.

Recruiting
Registry status
Phase 2
Development phase
35
Enrollment target
1
Study location

NCT07276789: Recruiting Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Integro Theranostics.

NCT07276789 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Integro Theranostics. The registered enrollment target is 35 participants, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07276789, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Integro Theranostics.

RECRUITING
Registry status
Phase 2
Development phase
35 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

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)

Interventions

  • DRUG LS301-IT 0.1 mg/kg

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2025-12-08
Est. Completion 2026-09
Phase Phase 2
Integro Theranostics

3 total trials

What NCT07276789 shows while recruiting

NCT07276789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which LS301-IT 0.1 mg/kg is the first listed.

NCT07276789 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT07276789 about?

NCT07276789 is a clinical study titled "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". 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 (Robot...

What is the current status of trial NCT07276789?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2025-12-08. Estimated completion is 2026-09.

What conditions does trial NCT07276789 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT07276789?

The interventions under investigation include: LS301-IT 0.1 mg/kg (DRUG).

Who is sponsoring clinical trial NCT07276789?

This trial is sponsored by Integro Theranostics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07276789 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-small Cell Lung Cancer (NSCLC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07276789's enrollment target sits among peer trials

35 49th of 59 higher than 11 of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07276789, the US trial registry maintained by the National Library of Medicine. NCT07276789 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.