Lumeda DigiLum™ is currently under evaluation in the clinical studies listed below that investigate safety and preliminary efficacy of PDT using our technology in our target indications in advanced lung and colorectal cancer.  

Our clinical plan first establishes safety of PDT administered in the pleura using our DigiLum™ system to activate the approved photosensitizer for treating NSCLC (porfimer sodium) to assess safety of PDT administered intraoperatively during standard of care VATS procedures. A follow-on study investigates safety and initial efficacy of intraoperative PDT in combination with an anti-PD1 immune checkpoint inhibitor to evaluate PDT as an immune adjuvant to enhance and amplify patient response to immunotherapy. A third study evaluates use of aminolevulinic acid (Gleolan™) as an imaging for image-guided surgical tumor resection in patients with advanced colorectal cancer, followed by intraoperative PDT to treat compromised surgical margins as well as eradicate microscopic residual disease. This study is the first to evaluate the dual diagnostic and therapeutic use of aminolevulinic acid in treatment of these patients.

ClinicalTrials.gov Identifier:   NCT03678350

Phase I Study

Light Dosimetry for Photodynamic Therapy With Porfimer Sodium in Treating Participants With Malignant Mesothelioma or Non-Small Cell Lung Cancer With Pleural Disease Undergoing Surgery

Sponsor:   Roswell Park Comprehensive Cancer Center

Principal Investigator:  Saikrishna Yendamuri MD

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:

To demonstrate that our light dosimetry system is safe and effective in guiding intraoperative photodynamic therapy with porfimer sodium (Photofrin).

Secondary Objectives:

1. To evaluate progression free survival (PFS) and overall survival (OS).
2. To examine the relationship between immune biomarkers and response.

ClinicalTrials.gov Identifier:   NCT04836429

Phase I Study

Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer With Pleural Disease or Malignant Pleural Mesothelioma

Sponsor:   Roswell Park Comprehensive Cancer Center

Principal Investigator:  Saikrishna Yendamuri MD

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 Objective:

To demonstrate that intraoperative photodynamic therapy with porfimer sodium (Photofrin®) can safely enhance the response to immunotherapy with an anti-PD-1 agent.

Secondary Objectives:

1. To assess the impact of adjuvant intraoperative PDT on progression free survival (PFS) and overall survival (OS) in patients with pleural malignancies treated with standard of care video-assisted thoracoscopic surgery/ talc poudrage (VATS / poudrage) plus immune checkpoint inhibition (ICI).
2. To monitor the systemic immune response over time. 

ClinicalTrials.gov Identifier:   NCT06307548

Phase I/II Study

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

Sponsor:   Roswell Park Comprehensive Cancer Center

Principal Investigator:  Anthony S. Dakwar MD

Summary:  This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer.

Primary Objectives:

1. To test the accuracy of image-guided fluorescence to detect residual disease. (Phase I)
2. To determine the safety of intraoperative PDT after fluorescence-guided surgery in patients with loco-regionally advanced or recurrent colorectal cancer undergoing surgery. (Phase I)
3. To determine the potential efficacy of intraoperative PDT (after image-guided fluorescence surgery). (Phase II)

Secondary Objectives:

1. To assess the potential efficacy of intraoperative PDT (after image-guided fluorescence surgery). (Phase I)
2. To assess the relationship between disease free survival and changes in levels of carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA). (Phase II)
3. To assess rate of recurrence by using standard-of-care computed tomography (CT) and/or magnetic resonance imaging (MRI). (Phase II)

Clinical Development Plan

Following safety of the combination therapy established in study ID NCT04836429, a Phase I/II open-label study will evaluate safety, tolerability, and preliminary anti-tumor activity of 5-ALA (Gleolan™) 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 anti-PD1 immune checkpoint inhibitor ± chemotherapy, and an interventional arm receiving intraoperative PDT + standard of care anti-PD1 immune checkpoint inhibitor ± chemotherapy. Lumeda intends to continue clinical evaluation of 5-ALA mediated fluorescence image guided surgery followed by intraoperative PDT for local tumor control in patients with colorectal cancer once safety and preliminary efficacy is established in study ID NCT06307548.