At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
VGT-309drug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Age 18-85 years
- ✓Lung nodule or mass suspected to be primary lung cancer or lung metastases
- ✓Scheduled for standard of care surgical resection with diagnostic and/or curative intent
- ✓ECOG performance status 0-2
Key exclusion· 4
- ✕Not a surgical candidate based on surgeon, anesthesiologist, or consulting physician opinion
- ✕Known allergy or reaction to indocyanine green (ICG), radiographic contrast agents, or VGT-309 components
- ✕Congenital long QT syndrome or QTcF > 450 ms (males) or > 470 ms (females)
- ✕Prisoner or institutionalized individual, or unable to provide informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating VGT-309 for Lung Cancer. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartMay 2022
First PostedJun 2022
Primary CompletionJun 2023
Study CompletionDec 2023
TodayJul 2026
First PostedJun 1, 2022
Enrollment StartMay 24, 2022
Primary CompletionJun 24, 2023
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago
Interventions
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.