Fluorescent abenacianine to help surgeons find lung tumors during surgery

A Phase 3, Multi-center, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Abenacianine (VGT-309), a Tumor-Targeted, Activatable Fluorescent Imaging Agent, to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung - VISUALIZE 2

This tests whether a fluorescent drug called abenacianine helps surgeons see and remove lung cancer or lung metastases during planned lung surgery in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vergent Bioscience, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 6 sites (Duarte, California and 5 other locations)
• Trial ID: NCT07499674 on ClinicalTrials.gov

What this trial studies

This Phase 3, multicenter, randomized and intrasubject-controlled trial gives participants an intravenous dose of abenacianine, a tumor-targeted activatable fluorescent agent, prior to lung tumor resection. During surgery, near-infrared (NIR) imaging is used to visualize fluorescence and guide identification of cancerous tissue, with a small control group receiving the agent but not NIR imaging. Safety, imaging accuracy, and whether the agent improves detection of tumor tissue are recorded and compared within subjects and across groups. Approximately 132 participants will be enrolled to ensure at least 115 evaluable participants undergo NIR imaging with abenacianine.

Who should consider this trial

Good fit: Adults aged 18 or older who are scheduled for surgical resection of a lung lesion for diagnostic or curative intent and who meet the study's medical and contraception requirements are ideal candidates.

Not a fit: People not having surgical resection, those who cannot receive the imaging agent or NIR imaging, pregnant or lactating individuals, and those recently in other interventional trials are unlikely to benefit.

Why it matters

Potential benefit: If successful, this could help surgeons detect cancer more precisely during lung operations, potentially reducing missed tumor tissue and improving surgical outcomes.

How similar studies have performed: Early-phase and other tumor-targeted fluorescent imaging studies, including prior investigations of abenacianine, have reported promising tumor-specific fluorescence signals, but large confirmatory Phase 3 evidence is still limited.

Eligibility criteria

Inclusion Criteria:

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 for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.
4. Meet all requirements for the planned surgery based on opinion of the surgeon, anesthesiologist, and/or other consulting physician.
5. Be able to 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 after treatment.
   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 after dosing.
6. Have not participated in an interventional clinical trial within the last 30 days.

Exclusion Criteria:

1. They have a known allergy or reaction to radiographic contrast agents, ICG, or any component of abenacianine.
2. They have received chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to study enrollment.
3. They have any other co-morbidity or habit that the Investigator believes will interfere with their ability to comply with and complete the study. They are not a candidate for standard of care surgery based on opinion of the surgeon, anesthesiologist, or other consulting physician.
4. They are prisoners, institutionalized individuals, or are unable to consent for themselves.

Where this trial is running

Duarte, California and 5 other locations

• City of Hope National Medical Center — Duarte, California, United States (Not_yet_recruiting)
• Orlando Health Cancer Center — Orlando, Florida, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
• St. Vincent's Hospital — Fitzroy, Victoria, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Brian York

Conditions Lung Cancer; Lung Metastases; Metastatic Cancer in Lung