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 the ability to access the treatment site with light delivery fiber optics via conventional bronchoscopes. However, use of PDT in treating lung cancer in the thoracic cavity, the site where it is most common, has been limited due to the difficulty and complexity of light targeting and dosimetry.
Lumeda’s DigiLum™ system is based on a novel optical surface applicator technology conceived and demonstrated by Roswell Park Comprehensive Cancer Center, which allows for light delivery and monitoring in direct contact with target tissue over curved, irregular surfaces- a breakthrough device for practical use of PDT in the thoracic cavity. Lumeda DigiLum™ system will be used in two clinical studies to study safety and effectiveness of PDT applied intraoperatively- first as an adjuvant immediately following NSCLC tumor surgical resection to reduce disease recurrence, and in another study as a combination therapy with immune checkpoint blockade to stimulate immune anti-tumor activity to enhance the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease.
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NCT03678350 |
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Q2-22 |
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NCT04836429 |
Q3-21 |
Q4-22 |
Q2-22 |
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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 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 our 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.
Primary Outcome Measures :
- Incidence of adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: Up to 30 days ]
The frequency of toxicities will be tabulated by grade across all dose levels and cycles. All subjects who receive any study treatment will be considered evaluable for toxicity.
Secondary Outcome Measures :
- Progression-free survival [ Time Frame: From time of surgery + photodynamic therapy (PDT) or, until start of a new treatment, disease progression or death (whichever occurs first), assessed up to 3 years ]
The estimated distribution of progression free survival will be obtained using the Kaplan-Meier method. Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
2. Overall survival (OS) [ Time Frame: From the time of treatment (surgery + PDT) until death from any cause, assessed up to 3 years ]
Estimates of quantities such as median survival will be obtained. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed.
3. Anti tumor response [ Time Frame: Up to 2 years ]
Monitor immune markers for correlation between the IO PDT treatments and local or distant disease recurrence.
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.
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.
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.