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.
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
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:
- Medical, surgical and medication history.
- Complete physical exam, including vital signs and height
- Weight (needed for dose calculation)
- Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies.
- 12-lead ECG.
- 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.
- Conditions
- Lung Cancer, Lung Metastases
- 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 group | Role | What they receive |
|---|---|---|
| 0.32 mg/kg VGT-309 | Experimental | 0.32 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.
Clinically Significant Events (CSE)
Proportion of subjects with at least one Clinically Significant Event (CSE) as defined by:
- 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.
- 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.
- 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.
- 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 - 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
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
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.
- First posted22 Nov 2023
- Study start5 Oct 2023
- Primary completion31 Oct 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Vergent Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Curtis Scribner, MD, Study director, Vergent Bioscience
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06145048
- Acronym / sponsor ID
- VISUALIZE / VGT-309-2B-2023
- Conditions
- Lung Cancer, Lung Metastases
- Keywords
- Lung Cancer, Metastatic Cancer in Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Vergent Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Medical, surgical and medication history.
- Complete physical exam, including vital signs and height
- Weight (needed for dose calculation)
- Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies.
- 12-lead ECG.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 0.32 mg/kg VGT-309 | Experimental | Drug: VGT-3090.32 mg/kg VGT-309 given over 15-20 minutes by syringe pump |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| VGT-309Also: abenacianineIntravenous drug to be given over 15-20 minutes by syringe pump. | Drug | 0.32 mg/kg VGT-309 |
Primary outcome
Clinically Significant Events (CSE)
Time frame: Day of surgery
Proportion of subjects with at least one Clinically Significant Event (CSE) as defined by: A. 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. B. 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. C. 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. D. Identification of lymph nodes by VGT-309 with NIR imaging confirmed by histologic examination to be cancerous.
3 secondary outcomes
1 - Positive Predictive Value
Time frame: Day of Surgery
Positive Predictive Value
Time frame: Day of Surgery
Sensitivity
Time frame: Day of Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The joint publication will be coordinated by Vergent. There is no need for individual sites to review specific IPD from other sites.
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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.
Curtis Scribner, MD study director
Vergent Bioscience
6 sites in 2 countries: see every site and its status.
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?
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.