Photodynamic therapy (PDT) is an established treatment modality for NSCLC, and currently indicated for the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated, as well as for reduction of obstruction and palliation of symptoms in patients with obstructing endobronchial NSCLC. Such endoluminal use of PDT is driven by easy access the treatment site with light delivery fiber optics via conventional bronchoscopes. However, use of PDT in treating lung cancer in the thoracic cavity has been limited due to the difficulty and complexity of light targeting and dosimetry. Lumeda’s DigiLum™ system overcomes these obstacles to allow practical use of PDT in the thoracic cavity.
DigiLum™ is under evaluation in two Phase I clinical studies to assess safety of intraoperative PDT applied in the pleura, and safety and initial efficacy assessment of intraoperative PDT in combination with immune checkpoint blockade to enhance host antitumor immunity.
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Study Start |
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NCT03678350 |
Q3-21 |
Recruiting |
Q3-22 |
Q3-23 | |
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NCT04836429 |
Q4-21 |
Recruiting |
Q3-23 |
Q4-23 | |
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ClinicalTrials.gov Identifier: NCT03678350
Title: Light Dosimetry for Intraoperative Photodynamic Therapy (IO-PDT) With Porfimer Sodium (PHOTOFRIN®) in Patients with Malignant Mesothelioma or Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease - Phase I Study
Sponsor: Roswell Park Comprehensive Cancer Center
Summary: This phase I trial studies the side effects and how well the light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma or non-small cell lung cancer with pleural disease undergoing surgery.
Primary Objective: Demonstrate that the light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium.
Secondary Objectives: 1. Evaluate progression free survival (PFS) and overall survival (OS), and 2. to examine the relationship between immune biomarkers and response.
OUTLINE: Participants receive porfimer sodium intravenously (IV) over 3-5 minutes and receive intraoperative photodynamic therapy (IO-PDT) via a light dosimetry system 24-48 hours later. After conclusion of study treatment, participants are followed up at 30 days, within 4 weeks from surgery and PDT and every 6 months for 2 years.
ClinicalTrials.gov Identifier: NCT04836429
Title: Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease - Phase I Study
Sponsor: Roswell Park Comprehensive Cancer Center
Summary: This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease.
Study Arms:
Experimental: Treatment (porfimer sodium, photodynamic therapy) Patients receive porfimer sodium IV over 3-5 minutes 24-48 hours prior to standard of care VATS, followed by photodynamic therapy
Primary Outcome Measures:
- Incidence of serious adverse events (SAE) [ Time Frame: 28 days post study-related immunotherapy ] Will be determined by recording the occurrence of SAE during the first 28 days post study-related immunotherapy. The SAE will be evaluated using the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Secondary Outcome Measures:
- Progression-free survival (PFS) [ Time Frame: assessed up to 2 years ] Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
- Overall survival (OS) [ Time Frame: assessed up to 2 years ] Will utilize Kaplan-Meier curves to descriptively examine dose level differences and generate summary statistics.
- Changes in the immune phenotype of peripheral blood CD8+ T cells [ Time Frame: Baseline up to 2 years ] Will be analyzed using a repeated measures analysis-of-variance (ANOVA) model with a factor for dose level time and a dose level by time interaction.
- Changes in platelet-to-lymphocyte ratio [ Time Frame: Baseline up to 2 years ] Will be analyzed using a repeated measures ANOVA model with a factor for dose level, time and a dose level by time interaction.
Clinical Plan
Following safety in NCT04836429, a Phase I/II open-label study will evaluate safety, tolerability, and preliminary anti-tumor activity of 5-ALA mediated intraoperative PDT in patients with metastatic NSCLC with pleural spread and PD-L1 TPS ≥1%–49%. The study will be conducted under a randomized, two-stage design with a control arm receiving standard of care ICI ± chemotherapy, and an interventional arm receiving intraoperative PDT + standard of care ICI ± chemotherapy.
