Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung. (NCT06145048) | Clinical Trial Compass
CompletedPhase 2
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
United States89 participantsStarted 2023-10-05
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion criteria
. 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:
. 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: