Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

Trial details

Who runs it

Impact Biotech Ltd

Trial code

NCT05918783

Record updated

2026. október 8.

Original description

Phase 1/1b, safety, feasibility, and light dose titration study followed by further study of therapeutic ablation effects.Read full original descriptionShow less

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.

Inclusion: Age ≥18; 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; 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.

Exclusion: Prior exposure to VTP or PDT treatments; Receiving any other investigational treatment; Patient has had major surgery within the last 4 weeks; 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); Patient has a lung cancer lesion >2cm in diameter, for the expansion cohort lesion >2-3 cm; Patient has cytologic or histologic evidence of nodal disease; Patient has a cancer diagnosis with active disease requiring further cancer therapy; Patient has porphyria or hypersensitivity to padeliporfin or porphyrin-like compounds or to any of its excipients; Co-morbidities:; Baseline hypoxia with O2 saturation <92% on 2L NC or more of oxygen; New York Heart Association (NYHA) stage III/IV heart failure; Unstable coronary artery disease or MI within the last 6 months; Uncontrollable clinically serious arrhythmia; Decompensated/clinically worsening interstitial lung disease or obstructive lung disease; Unstable cerebrovascular or peripheral vascular disease; Inability to stop anticoagulation or anti-platelet therapy peri-procedure; Evidence of clinically active infection requiring systemic (any route) antibiotic therapy. All prior infections must have resolved following optimal therapy; Patient has any acute or chronic condition assessed as clinically significant by Investigator which may preclude bronchoscopy procedure; History of medical or psychiatric disease which, in the view of the investigator, would preclude safe treatment or acceptable study compliance; Known severe pulmonary hypertension (mean pulmonary arterial pressure ≥ 50 mmHg); Patient has a lung lesion located less than 1 cm from the pleura or fissure; Tumor invades major vessels; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT05918783