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Lung CancerPhase 2VISUALIZENCT06145048

Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.

A Phase 2 study testing VGT-309 in people with Lung Cancer and Lung Metastases, run by Vergent Bioscience, Inc. at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Lung Metastases
What is being tested?
VGT-309
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
6 sitesin 2 countries
Study dates
5 Oct 2023to 20 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Be willing and able to sign the informed consent and comply with study procedures.
  • Be at least 18 years of age.
  • Meet the following conditions:
  • Female participants must be of non-childbearing potential, or, If of childbearing potential, be non-pregnant or non-lactating and agree to use highly effective contraception from screening through Day 30 after treatment.
  • Male participants, if not surgically sterilized, and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 30 days after treatment and agree not to donate semen during this waiting period.
  • Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
Show all 13Show fewer
  • Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or Intrauterine device or intrauterine hormone-releasing system NOTE: Subjects who abstain from heterosexual intercourse as their usual and preferred lifestyle, will not be required to use contraception as described above. They are required to maintain abstinence from screening through Day 30 after treatment.
  • Note: Subjects in a same sex relationship, must use a barrier form of contraception (e.g., condom, diaphragm) to protect against the transfer of the study drug in any bodily fluids.
  • Have a lung nodule or mass that might be considered primary lung cancer or lung metastases whether or not it is biopsy-proven before surgery.
  • Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent
  • Have acceptable kidney and liver functions at study entry as evidenced by:
  • ALT/AST < 1.5 times the upper limit of normal Calculated Creatinine Clearance (CrCl) ≥ 50 ml/min Total bilirubin < 1.5 times the upper limit of normal Have an ECOG score of 0-2. Meet all standard of care surgical and general anesthesia requirements. 7) Have not participated in an interventional clinical trial within the last 30 days.
  • -

Who cannot join

  • Not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
  • Have a known allergy or reaction to ICG, other radiographic contrast agent, or any component of VGT-309.
  • Have congenital long QT syndrome or QTcF > 470ms by history or at Screening ECG.
  • Prisoners, institutionalized individuals, or are unable to consent for themselves.
  • Have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Australia1 site

  • St. Vincent's Hospital

    Melbourne, Victoria, 3065

Other trials in Australia

About this study

Official title: A Phase 2, Multi-center, Open-label Study to Evaluate the Safety and Efficacy of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent, in Subjects Undergoing Surgery for Cancer in the Lung

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Read the detailed description

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study within 4 weeks prior to the anticipated dosing:

  1. Medical, surgical and medication history.
  2. Complete physical exam, including vital signs and height
  3. Weight (needed for dose calculation)
  4. Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies.
  5. 12-lead ECG.
  6. Serum pregnancy test for females of child-bearing potential.

After meeting all enrollment criteria, each subject will receive 0.32 mg/kg VGT-309 by IV administration 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Subjects will be observed for 1 hour after dosing is completed and asked about possible treatment emergent adverse events.

Subjects will undergo surgical resection within 12-36 hours after completion of VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens. (Refer to Efficacy Endpoints and Efficacy Assessments sections).

Following surgery, subjects will be monitored for safety during their hospitalization. Between 7 to 14 and 25 to 35 days after surgery, the subjects will return to the clinic or have a telehealth visit for final safety assessments. At the last visit, if there are no adverse events requiring further follow up, subjects will then be released from the study.

Being tested
VGT-309
Keywords
Lung Cancer, Metastatic Cancer in Lung
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VGT-309Drug

    Also called abenacianine

    Intravenous drug to be given over 15-20 minutes by syringe pump.

Study groups in NCT06145048
Study groupRoleWhat they receive
0.32 mg/kg VGT-309Experimental0.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump
Receives: Drug: VGT-309

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically Significant Events (CSE)

    Proportion of subjects with at least one Clinically Significant Event (CSE) as defined by:

    1. Intraoperative localization of one or more preoperatively identified lung lesions using VGT-309 with NIR imaging not found w/SOC; and confirmed by histologic examination to be other than normal lung tissue.
    2. Identification of one or more synchronous or occult lung lesions using VGT-309 with NIR imaging not found with SOC; and confirmed by histologic examination to be cancerous or precancerous.
    3. Identification of fluorescence within ≤10 mm from the inside edge of the closest staple line as measured by the investigator ex vivo in the operating room using NIR imaging, with pathologic margin confirmed by histologic examination to be ≤ 10 mm.
    4. Identification of lymph nodes by VGT-309 with NIR imaging confirmed by histologic examination to be cancerous.

    Measured: Day of surgery

Secondary outcomes (3)

  1. 1 - Positive Predictive Value

    1 - Positive predictive value (1 - PPV) is defined as the probability that a tissue sample does not contain cancer when it fluoresces in vivo.

    1 - PPV = (False Positives) / (True Positives + False Positives)

    Measured: Day of Surgery

  2. Positive Predictive Value

    Positive predictive value (PPV) is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces in vivo.

    PPV = (True Positives) / (True Positives + False Positives)

    Measured: Day of Surgery

  3. Sensitivity

    Sensitivity is defined as the probability that the tissue fluoresces in vivo when it is cancer, as confirmed by histology.

    Sensitivity = (True Positives) / (True Positives + False Negatives

    Measured: Day of Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start5 Oct 2023
  3. Primary completion31 Oct 2024
  4. Study completion20 Feb 2025

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open label study in which all subjects will receive a dose of 0.32mg/kg VGT-309 (based on their weight) at 12-36 hours pre-surgery.
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06145048
Sponsor's protocol ID
VGT-309-2B-2023
Acronym
VISUALIZE
Status last verified
Apr 2026
First submitted
13 Nov 2023
Last updated
13 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VGT-309 in people with Lung Cancer and Lung Metastases, run by Vergent Bioscience, Inc. at 6 sites in 2 countries.

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 13 inclusion and 5 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: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. 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?

Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (CSE) (time frame: Day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06145048.

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 13 May 2026.

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