Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
This study aims to evalaute the efficacy and safety of VGT-309, which is a tumour-targeting imaging agent, when used during an operation in people scheduled for surigcal removal or biopsy of suspicious or confirmed lung cancer.
Eligible participants will receive a single intravenous (IV) infusion of VGT-309, administered 36-96 hours before surgery (pre-operatively). Total participants will last approximately 35 days (excluding a 28-day screening period). During this time, participants will undergo safety monitoring, including blood and urine sample collections, vital sign checks, physical examinations, and ECGs.
This research aims to enable doctors to use VGT-309 as an intra-operative fluorescent imaging agent to differentiate lung cancer from surrounding normal tissue in the future.
Conditions
This trial is treating people with non-small cell lung cancer
Eligibility
Inclusion
1. Be willing and able to sign the informed consent and comply with study procedures
2. Be at least 18 years of age
3. Be scheduled to undergo planned standard of care surgical resection for a lung nodule or mass, whether or not it is biopsy-proven
4. Have an ECOG score of 0-1
5. Have an acceptable hematologic and coagulation status and kidney and liver functions at study entry
6. Be male or female and meet the following conditions:
a. Female participants must be of non-childbearing potential, or,
b. If of childbearing potential be non-pregnant or lactating and agree to use highly effective contraception from screening through Day 30.
c. 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 90 days post-dose and agree not to donate semen during this waiting period.
d. 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.
7. Are judged to be an acceptable surgical risk by the operating surgeon and the anesthesiologist/anesthetist.
8. Have not participated in a clinical trial within the last 30 days.
Exclusion
1. Have a history of myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment.
2. Have any other condition that causes the Investigator to deem them unfit for lung resection.
3. Are receiving a Class IA (i.e. quinidine, procainamide) or Class III (i.e. dofetilide, amiodarone, sotalol) antiarrhythmic agents
4. Have congenital long QT syndrome or QTcF > 450 ms (males) or >470 ms (females) by history or at Screening ECG.
5. Have a history or evidence of interstitial pneumonitis or pulmonary fibrosis
6. A known allergy or reaction to ICG or other radiographic contrast agents
7. Any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Vergent Bioscience Australia, Pty Ltd.
Scientific Title
A Phase 2, Open-label Study to Evaluate the Safety, Efficacy, Dosing, and Timing of VGT-309, a Tumor-Targeted, Activatable Fluorescent Imaging Agent for the Intraoperative Identification of Lung Cancer
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