Clinical Studies

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 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 alter the tumor microenvironment and stimulate host anti-tumor immune activity.

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:

1. 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:

1. 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.
2. 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.
3. 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.
4. 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

A Phase II study to evaluate safety and efficacy of intraoperative PDT followed by immune checkpoint inhibitor (ICI) in NSCLC with pleural effusion is planned to commence once the safety endpoint is achieved in NCT04836429.  This study will be a three cohort, two-stage design of both chemonaive and patients who have failed prior ICI. A study protocol synopsis has been drafted and reviewed by the FDA.