Padeliporfin VTP for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called Padeliporfin VTP for individuals with early-stage lung cancer who plan to undergo surgery. The study aims to determine the safety and effectiveness of this treatment, which uses light to target and destroy cancer cells in the lungs. Participants should have a small lung tumor (less than 3 cm) at high risk for cancer, but not located too close to the center of the chest. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be able to stop anticoagulation or anti-platelet therapy around the time of the procedure.
What prior data suggests that this robotic assisted bronchoscopic Padeliporfin VTP lung ablation is safe for patients with lung cancer?
Research has shown that Padeliporfin VTP, the treatment used in this trial for lung cancer, is safe in other applications. It has proven safe and effective for treating low-risk prostate cancer, with most patients tolerating it well and no major safety issues reported.
While specific safety data for lung cancer is not yet available, its success in prostate cancer suggests it might be well-tolerated. This trial is in its early stages, focusing on identifying the safest dose. Researchers closely monitor patient responses to ensure safety.12345Why do researchers think this study treatment might be promising for lung cancer?
Unlike the standard treatments for lung cancer, which typically include surgery, chemotherapy, and radiation therapy, Padeliporfin VTP offers a novel approach by using a light-activated drug. This treatment involves administering Padeliporfin, which is activated by a specific laser light to target cancer cells directly. Researchers are excited because this method has the potential to minimize damage to surrounding healthy tissues and reduce side effects, offering a more precise and potentially less invasive treatment option for lung cancer patients.
What evidence suggests that Padeliporfin VTP might be an effective treatment for lung cancer?
Studies have shown that Padeliporfin VTP, a type of light-based therapy, effectively treats certain cancers. For instance, it has successfully managed prostate cancer and low-grade upper tract urothelial cancer. This treatment uses light to activate a drug called Padeliporfin, which targets and destroys cancer cells. Previous results demonstrated that it can reduce cancer with minimal side effects. In this trial, participants will receive Padeliporfin VTP to assess its safety and effectiveness for lung cancer. Although less information exists specifically for lung cancer, promising results in other cancers suggest it might be effective.678910
Who Is on the Research Team?
Lonny Yarmus, DO
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults with early-stage peripheral lung cancer, who are high-risk surgical candidates. Eligible patients must have a tumor ≤3cm based on CT scans and confirmed malignancy via biopsy. The tumor should be accessible by robotic bronchoscopy, not too close to the central airways or pleura, and without nodal involvement of cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Robotic assisted bronchoscopic Padeliporfin VTP lung ablation with light dose escalation to determine MTD/RP2D
Surgery
Surgery performed 5-21 days following the VTP procedure to assess feasibility and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of treatment-related adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Padeliporfin VTP
Padeliporfin VTP is already approved in European Union for the following indications:
- Low-risk prostate cancer
- Upper tract urothelial carcinoma (UTUC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Impact Biotech Ltd
Lead Sponsor
Steba Biotech S.A.
Lead Sponsor
Impact biotech Ltd.
Collaborator