Padeliporfin 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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
Exclusion Criteria:
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.
Primary outcome measure(s)
Safety of robotic assisted bronchoscopic Padeliporfin VTP ablation — Day 30 Incidence of treatment-related adverse events as assessed by CTCAE v5.0
Feasibility of robotic assisted bronchoscopic Padeliporfin VTP treatment — Day 1 Feasibility of robotic bronchoscopic light fiber delivery into the target lesion as confirmed by cone beam CT and complete VTP treatment
Evaluate Maximum Tolerated light Dose and/or RP2D of Padeliporfin VTP ablation — Day 14 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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