Leucoselect Phytosome for Neoadjuvant Treatment of Early Stage Lung Cancer

Summary

Lung cancer is the leading cause of cancer death in the country, surpassing deaths caused by colorectal, prostate and breast cancers combined. Veterans are at higher risk of lung cancer due to the higher rate of smoking and environmental toxin exposures. The lack of effective therapy for lung cancer provides the impetus to search for alternative, safe, and effective treatment agents to improve treatment strategy against lung cancer, enhance the probability of a cure and reduce recurrence. Based on encouraging preclinical and clinical findings from an early phase I lung cancer prevention study, using a special formulation of a standardized grape seed extract with enhanced absorption called leucoselect phytosome (LP), the purpose of this new CSR\&D Merit Review project is to evaluate the potential usefulness of LP for pre-surgical treatment of early stage lung cancer patients in a phase IIa clinical trial. Findings from this study may set the stage for larger, confirmatory trials in the near future.

Timeline

Start

2023-11-20

Primary completion

2024-11-01

Completion

2025-03-31

Outcome

Outcome not reported

Stopped (Enrollment): “Early termination by sponsor due to substantial delays with subjects recruitment”

Drugs

Indications