RecruitingPhase 1NCT05918783

Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer

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


Sponsor

Impact Biotech Ltd

Enrollment

36 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a light-activated treatment called padeliporfin VTP (vascular targeted photodynamic therapy) delivered through a robotic bronchoscope to destroy small peripheral lung tumors — those located near the outer edges of the lung. The treatment is done before standard surgery to see if it can effectively kill tumor cells while preserving healthy lung tissue. **You may be eligible if:** - You are 18 or older - You have a small lung lesion (tumor up to 2–3 cm) that is suspected or confirmed to be primary lung cancer - Your tumor is located in the outer part of the lung, at least 2 cm away from major airways and major blood vessels - Your tumor is not attached to or very close to the outer lung surface (pleura) - A multidisciplinary team has approved you for this bronchoscopic procedure before surgery - You can tolerate bronchoscopy under general anesthesia - Your organ function is adequate and life expectancy is at least 3 months **You may NOT be eligible if:** - Your tumor is centrally located near major airways or large blood vessels - Your tumor is larger than the allowed size limit - You have lymph node involvement detected at the time of bronchoscopy - You have certain conditions that make bronchoscopy or general anesthesia unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

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NCT05918783