Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

Eligibility Criteria

• 1. Age ≥18
• 2. Patients with primary lung lesions who are at high risk for primary lung cancer.
• 2.1.Biopsy with intraoperative confirmation of malignancy using on-site cytology will be used as final inclusion prior to study treatment.
• 3. 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.
• 4. Tumor size targeted for VTP treatment ≤ 2 cm (Part A) and \<3cm (Part B), based on CT scan, including solid or semi-solid tumors.
• 5. EBUS mediastinal staging performed intraoperative prior to VTP treatment with rapid on-site evaluation negative for nodal involvement of malignancy.
• 6. 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).
• 7. Lung lesion is not contiguous with and ≥ 1 cm from the pleura/fissures.
• 8. Patient is eligible to undergo bronchoscopy under general anesthesia.
• 9. Tumor is accessible for Padeliporfin VTP treatment via robotic bronchoscopy
• 10. ECOG performance score 0-2
• 11. Estimated life expectancy of ≥3 months
• 12. Adequate organ system function
• 13. Negative serum pregnancy test
• 1. Patient has a centrally located lung lesion, as defined by RTOG within 2 cm of the proximal bronchial tree, or within 2 cm of other major mediastinal structure (aorta, heart, trachea, pericardium, superior vena cava, pulmonary artery, esophagus, vertebra's body or spinal canal).
• 2. Patient has a lung lesion located less than 1 cm from the pleura or fissure
• 3. Patient has a lung cancer lesion \>2cm in diameter, for the expansion cohort lesion \>2-3 cm
• 4. Patient has cytologic or histologic evidence of nodal disease
• 5. Tumor invades major vessels
• 6. Prior exposure to VTP or PDT treatments
• 7. Pregnant or breastfeeding women
• 8. Receiving any other investigational treatment
• 9. Co-morbidities:
• 1. Baseline hypoxia with O2 saturation \<92% on 2L NC or more of oxygen
• 2. New York Heart Association (NYHA) stage III/IV heart failure
• 3. Unstable coronary artery disease or MI within the last 6 months
• 4. Uncontrollable clinically serious arrhythmia
• 5. Decompensated/clinically worsening interstitial lung disease or obstructive lung disease.
• 6. Unstable cerebrovascular or peripheral vascular disease
• 7. Inability to stop anticoagulation or anti-platelet therapy peri-procedure
• 8. Evidence of clinically active infection requiring systemic (any route) antibiotic therapy. All prior infections must have resolved following optimal therapy.
• 9. Patient has any acute or chronic condition assessed as clinically significant by Investigator which may preclude bronchoscopy procedure
• 10. History of medical or psychiatric disease which, in the view of the investigator, would preclude safe treatment or acceptable study compliance
• 11. Known severe pulmonary hypertension (mean pulmonary arterial pressure ≥ 50 mmHg)
• 10. Patient has a cancer diagnosis with active disease requiring further cancer therapy.
• 11. Patient has had major surgery within the last 4 weeks.
• 12. Patient has porphyria or hypersensitivity to padeliporfin or porphyrin-like compounds or to any of its excipients.