A Multicenter Open-label Phase 1/1b Study to Evaluate Safety, Feasibility and Early Treatment Effect of Padeliporfin VTP Using Robotic Assisted Bronchoscopy and Cone Beam CT Guidance in Patients With Peripheral Lung Cancer
Summary
Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects. Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Surgery will be performed at 5-21 days following the VTP procedure. Study intervention: robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer.
Detailed description
A multicenter, open label, phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects. Patients with high risk of peripheral primary lung cancer, stage 1A1/1A2, for whom surgical treatment is planned, will be recruited. Patients who are candidates for lung resection will be recruited as a diagnose and treat in the same anaesthesia, protocol; surgery will be performed at least 5 days and up to 21 days following the VTP procedure. Study intervention will consist of robotic assisted bronchoscopic Padeliporfin VTP lung ablation: vascular targeted photodynamic therapy using Padeliporfin photosensitizer, an ablation mechanism with efficacy related to immune response post-ablation.
Arms & interventions
- Combination ProductPadeliporfin Vascular Targeted Photodynamic (VTP) therapy
Bronchoscopy will be performed with robotic assisted approach using standard practices using general anaesthesia and placement of the optic fiber intratumorally followed by IV administration of Padeliporfin for 10 min and laser light illumination.
Outcome measures
Primary
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation
Incidence of treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 30
Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatment
Feasibility of robotic bronchoscopic light fiber delivery into the target lesion as confirmed by cone beam CT and complete VTP treatment
Time frame: Day 1
Evaluate Maximum Tolerated light Dose and/or RP2D of Padeliporfin VTP ablation
Evaluate Maximum Tolerated light Dose and/or RP2D of robotic assisted bronchoscopic Padeliporfin VTP ablation (a vascular targeted photodynamic therapy with Padeliporfin of patients with peripheral stage 1A1/1A2) primary non-small cell lung cancers.
Time frame: Day 14
Secondary
Evaluation lung surgery feasibility
Time frame: Day 5-21
Evaluation of the ablation area
Time frame: 2 days post Padeliprofin VTP
Eligibility criteria
Study locations (1)
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224