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
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.
• Age ≥18
• Patients with primary lung lesions who are at high risk for primary lung cancer.
‣ 1.Biopsy with intraoperative confirmation of malignancy using on-site cytology will be used as final inclusion prior to study treatment.
• All patients will be approved by a multi-disciplinary team (thoracic surgery, interventional pulmonology, medical oncology and radiation oncology) as appropriate for bronchoscopic VTP prior to surgical resection.
• Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
• EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
• Tumor is ≥ 2cm from the central bronchial tree (distal 2 cm of the trachea, carina, and named major lobar bronchi up to their first bifurcation) (Timmerman, 2018).
• Lung lesion is not contiguous with and ≥ 1 cm from the pleura/fissures.
• Patient is eligible to undergo bronchoscopy under general anesthesia.
• Tumor is accessible for Padeliporfin VTP treatment via robotic bronchoscopy
⁃ ECOG performance score 0-2
⁃ Estimated life expectancy of ≥3 months
⁃ Adequate organ system function
⁃ Negative serum pregnancy test