Evaluation of the Safety and Efficacy of WST11-mediated Vascular Targeted Photodynamic Therapy on Obstructing Endobronchial Non-Small Cell Lung Cancer
This study is designed as a multicentre, exploratory phase IIa, open label, single
intravenous (IV) dose, escalating treatment regimen (Treatment regimen = a single dose of
WST11 associated with a particular laser light energy) with a one month follow-up.
Six escalating treatment regimens will be followed: 3 WST11 doses (5 mg/kg; 7.5 mg/kg and 10
mg/kg) combined with 2 light energies (200 Joules/cm and 300 Joules/cm)
The patient will be treated under local anesthesia. The light is produced using a specific
laser at a wavelength of 753 nm at a fixed power of 250 mW/cm and locally delivered to the
obstructing tumor through an optical fiber placed, during endoscopy, in the endoscope
operating channel with visual control, possibly video-transmission assisted. The fiber
illuminating diffusion length is fixed (2 cm).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The percentage of bronchial obstruction before and after treatment represents the main evaluation parameter.
Week 1, Month 1
Michel Leroy, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)