Non Small Cell Lung Cancer (NSCLC)Phase 2NCT07276789
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 testing LS301-IT 0.1 mg/kg in people with Non Small Cell Lung Cancer (NSCLC), run by Integro Theranostics at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- LS301-IT 0.1 mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Dec 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Iowa
Iowa City, Iowa, 52242
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection
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).
Read the detailed description
The primary objective of the study is to determine the proportion of subjects that have at least one Clinically Significant Event (CSE) using fluorescence imaging, defined as either the localization of the primary tumor when white light has failed to identify the tumor, the identification of a synchronous or occult pulmonary tumor with fluorescence only, or the identification of an inadequate surgical margin after resection. Secondary objectives include the determination of the sensitivity and positive predictive value (PPV) of LS301 fluorescence imaging in the identification of tumor using histopathology as the gold standard, and the assessment of the safety and tolerability of LS301-IT. Exploratory objectives include the determination of the "Clinical Impact Rate" defined as the proportion of cases when the surgeon changes the scope of the procedure based on LS301 fluorescence imaging, the assessment of the dosing interval prior to surgery, and the standardization of imaging during surgery and surgeon assessment of fluorescence.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- LS301-IT 0.1 mg/kg
- Keywords
- lung cancer, lung cancer resection, Non Small Cell Lung Cancer Resection, Non-Small Cell Lung Cancer Stage I-II
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS301-IT 0.1 mg/kgDrug
Single dose of LS301-IT administed up to 4 days prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| LS301-IT 1.0 mg/kg | Experimental | Not described Receives: Drug: LS301-IT 0.1 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Significant Events
To determine the proportion of subjects that have at least one CSE where a CSE is defined as one of 3 possible clinical events:
- 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)
Measured: On the day of surgery
Secondary outcomes (6)
Sensitivity
The number of patients that are true positive divided by the number of patients that are true positive + the number of patients that are false positive (True Positive/True Positive + False Negative) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard
Measured: day or surgery
Positive Predictive Value
Number of patients that are true positive divided by the number of patients that are true positive + false positive (True Positive/(True Positive + False Positive) of fluorescence IMI using intraoperative surgeon assessment with histopathology as the gold standard
Measured: day of surgery
Primary tumor identification rate
Proportion of patients that underwent flourescent imaging where the primary tumor was identified by flourescence
Measured: day of surgery
Synchronous or occult tumor identification rate
Propotion of the total number of synchronous or occult tumors identified by flourescent imaging
Measured: day of surgery
Close margin rate
The proportion of patients with a close margin identified by fluorescent imaging. Close margin is defined as a margin within less than or equal to 5 mm from the staple line and less than or equal to 10 mm from the staple line
Measured: day of surgery
Incidence of Adverse Events
The proportion of patients reporting at least one adverse event
Measured: within 30 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start8 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-dose, open-label, multicenter, Phase 2 study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS or RATS). Single dose IV infusion of 0.1 mg/kg of LS301-IT given up to 4 days before surgery. There will be no stratification by dosing interval, type of minimally invasive surgery, or tumor type.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integro Theranostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Honigberg, MD, Study director, Integro Theranostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276789
- Sponsor's protocol ID
- LS301-IT-B201
- Status last verified
- Nov 2026
- First submitted
- 1 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: As the study is an early stage study, there is no current plan to share the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection
- ClinicalTrials.gov ID
- NCT07276789
- Acronym / sponsor ID
- LS301-IT-B201
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Keywords
- lung cancer, lung cancer resection, Non Small Cell Lung Cancer Resection, Non-Small Cell Lung Cancer Stage I-II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Integro TheranosticsIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The primary objective of the study is to determine the proportion of subjects that have at least one Clinically Significant Event (CSE) using fluorescence imaging, defined as either the localization of the primary tumor when white light has failed to identify the tumor, the identification of a synchronous or occult pulmonary tumor with fluorescence only, or the identification of an inadequate surgical margin after resection. Secondary objectives include the determination of the sensitivity and positive predictive value (PPV) of LS301 fluorescence imaging in the identification of tumor using histopathology as the gold standard, and the assessment of the safety and tolerability of LS301-IT. Exploratory objectives include the determination of the "Clinical Impact Rate" defined as the proportion of cases when the surgeon changes the scope of the procedure based on LS301 fluorescence imaging, the assessment of the dosing interval prior to surgery, and the standardization of imaging during surgery and surgeon assessment of fluorescence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-dose, open-label, multicenter, Phase 2 study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS or RATS). Single dose IV infusion of 0.1 mg/kg of LS301-IT given up to 4 days before surgery. There will be no stratification by dosing interval, type of minimally invasive surgery, or tumor type.
| Arm | Type | Receives |
|---|---|---|
| LS301-IT 1.0 mg/kg | Experimental | Drug: LS301-IT 0.1 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LS301-IT 0.1 mg/kgSingle dose of LS301-IT administed up to 4 days prior to surgery | Drug | LS301-IT 1.0 mg/kg |
Primary outcome
Clinically Significant Events
Time frame: On 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)
6 secondary outcomes
Sensitivity
Time frame: day or surgery
Positive Predictive Value
Time frame: day of surgery
Primary tumor identification rate
Time frame: day of surgery
Synchronous or occult tumor identification rate
Time frame: day of surgery
Close margin rate
Time frame: day of surgery
Incidence of Adverse Events
Time frame: within 30 days after dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. As the study is an early stage study, there is no current plan to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Honigberg, MD study director
Integro Theranostics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LS301-IT 0.1 mg/kg in people with Non Small Cell Lung Cancer (NSCLC), run by Integro Theranostics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Events (time frame: On the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.