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Lung CancerPhase 2NCT05400226

Phase 2 Study of VGT-309 in Lung Cancer

A Phase 2 study testing VGT-309 in people with Lung Cancer, run by Vergent Bioscience, Inc. at 1 site in United States.

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

A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Lung Cancer
What is being tested?
VGT-309
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
24 May 2022to 15 Dec 2023
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 to 85 years
  • 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 between the ages of 18 and 85, inclusive.
  • Be male or female and 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.
  • 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 post-dose and agree not to donate semen during this waiting period.
Show all 19Show fewer
  • Highly effective contraception involves the use of a condom for the male, plus one of the following for the female:
  • Oral, injectable, implantable, intravaginal, or transdermal hormonal contraceptives, or
  • Intrauterine device or intrauterine hormone-releasing system
  • NOTE: Participants 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.
  • Have a lung nodule or mass that might be considered primary lung cancer or lung metastases, whether or not it is biopsy-proven.
  • Be scheduled to undergo standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent and meet all pre-operative surgical and anesthesia acceptance criteria.
  • Have acceptable kidney and liver functions at study entry as evidenced by:
  • Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) < 1.5 times the upper limit of normal
  • Serum creatinine < 1.5 times the upper limit of normal
  • Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2.
  • Meet all standard surgical and general anesthesia requirements.
  • Have not participated in a clinical trial within the last 30 days.

Who cannot join

  • They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
  • They have a known allergy or reaction to indocyanine green (ICG), other radiographic contrast agent, or any component of VGT-309.
  • Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by history or at Screening ECG.
  • They are 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

1 site in 1 country.

United States1 site

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.

Read the detailed description

A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer surgery. A total of 40 subjects will be enrolled to ensure at least 38 evaluable subjects with the option to expand enrollment by protocol amendment if deemed necessary to meet primary and/or secondary objectives.

Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study. Assessments include the following, unless they have been done within 4 weeks prior to the anticipated dosing:

  1. Medical, surgical and medication history.
  2. Complete physical exam, including vital signs and weight.
  3. Standard pre-operative chemistry, hematology, coagulation and urinalysis clinical laboratory studies.
  4. 12-lead ECG.
  5. Serum pregnancy test for females of child-bearing potential.

Following clearance of all enrollment criteria, each subject will receive an IV administration of 0.32 mg/kg VGT-309 at 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Upon dosing, subjects will be observed for up to 2 hours and asked about possible treatment emergent adverse events.

Subjects will undergo surgical resection as planned and within the time specified following VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens.

Following surgery, subjects will be monitored for safety during their hospitalization. After discharge from the hospital, and approximately 14 days post-surgery, the subjects will be contacted by telephone to assess their well-being. Between 19 to 39 days post-surgery, subjects will either return to the clinic or participate in a telehealth visit for final safety assessments. If there are no adverse events requiring further follow up, subjects will then be released from the study.

Conditions
Lung Cancer
Being tested
VGT-309
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

    VGT-309 is an tumor-targeted, activatable fluorescent imaging agent which will be used with near infrared imaging during surgery to identify tumor.

Study groups in NCT05400226
Study groupRoleWhat they receive
0.32mg/kg VGT-309ExperimentalSingle arm in an open label study
Receives: Drug: VGT-309

What is being measured

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

  1. Clinically Significant Event (CSE)

    Identification of the proportion of subjects with at least one CSE as defined by:

    1. Localization of a Pulmonary Nodule using VGT-309 near-infrared (NIR) Imaging when white light and palpation failed to identify a nodule.
    2. Synchronous Lesion Identification using VGT-309 NIR Imaging when not identified by white light and palpation.
    3. Positive Margin Identification with only VGT-309 NIR Imaging when deemed negative by the surgeon by white light and palpation.

    Measured: Day of surgery

Secondary outcomes (4)

  1. Sensitivity

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

    Sensitivity = (True Positive)/(True Positive + False Negative)

    Measured: Day of surgery

  2. Negative Predictive Value

    Negative predictive value is defined as the probability that a tissue sample does not contain cancer on histologic exam if it does not fluoresce intraoperatively.

    Negative Predictive Value = (True Negative)/(True Negative + False Negative)

    Measured: Day of surgery

  3. Specificity

    Specificity is defined as the probability that tissue does not fluoresce intraoperatively when it is not cancerous as confirmed by histology.

    Specificity = (True Negative)/(True Negative + False Positive)

    Measured: Day of surgery

  4. Positive Predictive Value

    Positive predictive value is defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces intraoperatively.

    Positive Predictive Value = (True Positive)/(True Positive + False Positive)

    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 posted1 Jun 2022
  2. Study start24 May 2022
  3. Primary completion24 Jun 2023
  4. Study completion15 Dec 2023

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
All subjects to be dosed at the same dose level. This is open label and no randomization is required.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400226
Sponsor's protocol ID
VGT-309-2-2021USA
Other IDs
1R44CA277890-01
Status last verified
Sep 2024
First submitted
26 May 2022
Last updated
17 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bou-Samra P, Singhal S. Precision Oncology in Lung Cancer Surgery. Hematol Oncol Clin North Am. 2026 Oct;40(5):797-806. doi: 10.1016/j.hoc.2026.05.018.

    PubMed 42686329

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VGT-309 in people with Lung Cancer, run by Vergent Bioscience, Inc. at 1 site 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 19 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 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 17 Oct 2024). 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 Event (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 NCT05400226, which also lists 1 linked publication.

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 17 Oct 2024.

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