Clinical Studies

Photodynamic therapy (PDT) is an established treatment modality for NSCLC. Porfimer Sodium (PHOTOFRIN®) is an approved photosensitizer agent for treating lung cancer in the United States, 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.  Lumeda DigiLum™ is a complete PDT system to be indicated for use in activating PHOTOFRIN® in an intraoperative PDT (IO-PDT) procedure immediately following NSCLC tumor resection as an adjuvant to surgical resection. Residual disease after surgical resection is a significant cause for local recurrence of NSCLC, which remains a significant problem despite modest improvement in survival from adjuvant chemotherapy.  Use of IO-PDT can effectively treat undetected cancer cells by illuminating margins in the surgical bed before wound closure as a single adjuvant treatment delivered at time of surgery.  Such local therapy to the regional lymph node basin, delivered immediately following resection of the primary tumor, presents a novel therapeutic paradigm that promises to dramatically reduce recurrence.

Lumeda has initiated three clinical studies to first establish safety (Phase I), followed by effectiveness (Phase II) of IO-PDT as an adjuvant to NSCLC tumor resection using the DigiLum™ system.  In addition, the study plan will include assessment of the effect of PDT on the immune contexture of NSCLC patients, as well as establishing safety of PDT (Phase I study) when used in Combination PDT + Immunotherapy.

Study

        Design

         Approval

           Study Start

                  Primary Completion

            Initial Results

Phase 1 PDT Light Dosimetry

✔

✔

Q1-21

Q4-22

Q3-22

Phase I Combination PDT-Immunotherapy

✔

Q1-21

Q2-21

Q2-22

Q1-22

Phase II PDT Light Dosimetry

Q3-22

Q4-22

Q1-23

Q2-24

Q1-24

 

Phase I PDT Light Dosimetry

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

ClinicalTrials.gov Identifier:   NCT03678350

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 

Phase I Combination PDT-Immunotherapy (Information to be published once listed on the NIH clinical studies registry)

Title:   TBD
ClinicalTrials.gov Identifier:   TBD
Sponsor:   Roswell Park Comprehensive Cancer Center
Summary:  TBD
Primary Objective: TBD
Secondary Objectives:   TBD

Phase II PDT Light Dosimetry (Information to be published once listed on the NIH clinical studies registry)

Title:   TBD
ClinicalTrials.gov Identifier:   TBD
Sponsor:   Roswell Park Comprehensive Cancer Center
Summary:  TBD
Primary Objective: TBD
Secondary Objectives:   TBD