Clinical Trials

Inclusion Criteria:

1. Be willing and able to sign the informed consent and comply with study procedures.

2. Be between the ages of 18 and 85, inclusive.

3. Be male or female and meet the following conditions:

1. Female participants must be of non-childbearing potential, or,

2. If of childbearing potential be non-pregnant or non-lactating and agree to use
highly effective contraception from screening through Day 30.

3. 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.

4. 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.

4. Have a lung nodule or mass that might be considered primary lung cancer or lung
metastases, whether or not it is biopsyproven.

5. 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.

6. Have acceptable kidney and liver functions at study entry as evidenced by:

1. ALT/AST < 1.5 times the upper limit of normal

2. Serum creatinine < 1.5 times the upper limit of normal

7. Have an ECOG score of 0-2.

8. Meet all standard surgical and general anesthesia requirements.

9. Have not participated in a clinical trial within the last 30 days.

Exclusion Criteria:

1. They are not a candidate for standard of care surgery based on opinion of the surgeon,
anesthesiologist, or other consulting physician.

2. They have a known allergy or reaction to ICG, other radiographic contrast agent, or
any component of VGT-309.

3. Have congenital long QT syndrome or QTcF > 450ms (males) or >470ms (females) by
history or at Screening ECG.

4. They are prisoners, institutionalized individuals, or are unable to consent for
themselves.

5. Have any other co-morbidity or habit that the Investigator believes will interfere
with their ability to comply with and complete the study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/31/23. Questions regarding updates should be directed to the study team contact.