Oncolux’s™ groundbreaking photodynamic therapy (PDT) is currently being evaluated in clinical trials for advanced lung and colorectal cancer, exploring its safety and efficacy in these critical areas of unmet need.
OncoLux Clinical Development Plan
OncoLux is implementing a clinical development plan focused on two lead indications- one in advanced colorectal cancer, the other in advanced lung cancer. These indications address an unmet need in the standard of care for these patients that can be addressed with adjuvant PDT administered by the company product.
Phase 1 Studies
Patients with NSCLC with pleural spread or other malignant pleural disease
Our PDT therapy is intended for use in patients with late-stage NSCLC with pleural spread or other malignant pleural disease in combination with α-PD1 immunotherapy to amplify patient response to immunotherapy. Intraoperative PDT is administered during standard of care procedures in treating patients with pleural disease including thoracentesis, medical thoracoscopy, and pleurodesis.
The DigiLum™ device has been approved for clinical use (IDE) in three Phase I studies. The first study (NCT03678350) evaluates safety of the system for administering intraoperative PDT to patients with advanced NSCLC with pleural spread following video-assisted thoracoscopic surgery (VATS) tumor resection. The study achieved its safety endpoint with no reported adverse events (AEs). A second Phase I study (NCT04836429) evaluates safety of combination PDT + αPD-1 immunotherapy in treating patients with advanced NSCLC with pleural spread. In both studies, PDT was applied intraoperatively during pleurodesis or medical thoracoscopy, and achieved safety endpoints with no reported AEs. Patient treatments are complete in both studies, and are currently in a 2-year follow up period.
A Phase I/II study (NCT06307548) evaluates the use of 5-aminolevulinic acid (Gleolan®) as an imaging agent for fluorescence guided surgery (FGS) followed by intraoperative PDT for treating patients with advanced colorectal cancer with recurrent or T4 tumors undergoing surgery. Phase 1 of the study was completed in 2024 with no AEs, achieving its safety primary endpoint.
Phase 2 Studies
Patients with advanced colorectal cancer that are candidates for surgical resection
Patients are given Gleolan® as an optical imaging agent for fluorescence guide surgery (FGS) of malignant tissue in patients with recurrent or T4 colorectal tumors for precision surgical resection followed by intraoperative PDT. By illuminating the entire surgical bed immediately post-resection, intraoperative PDT can effectively treat positive surgical margins as well as microscopic residual disease.
NCT06307548 has been approved to advance into Phase 2. The Phase 2 primary endpoint will determine the potential efficacy of intraoperative PDT after image-guided fluorescence surgery using Gleolan®. This Phase 2 study is open and recruiting patients.
| Study ID | Study Start | Status | Primary Completion | Primary Endpoint |
|---|---|---|---|---|
| NCT03678350 | Q3-21 | Active / Not Recruiting | Q3-23 | Q4-23 |
| NCT04836429 | Q4-21 | Active / Not Recruiting | Q3-24 | Q3-24 |
| NCT06307548 Phase 1 | Q2-24 | Active / Not Recruiting | Q4-24 | Q1-25 |
| NCT06307548 Phase 2 | Q1-25 | Recruiting | Q1-26 | Q2-26 |
A Phase I/II follow on of NCT04836429 is planned as a multi-center, open-label study for evaluating intraoperative PDT using 5-ALA in combination with αPD-1 immunotherapy for the treatment of patients with malignant pleural disease. A Phase 1 safety run-in study will evaluate safety of 5-ALA mediated intraoperative PDT in combination with standard of care αPD-1 immunotherapy. Phase 2 will be a randomized, two-stage design with a control arm receiving standard of care αPD-1 immunotherapy, and an interventional arm receiving intraoperative PDT + standard of care αPD-1 immunotherapy. The Phase 2 primary endpoint is Overall Response Rate (ORR) to assess efficacy of the combination therapy over current standard of care. The study is expected to open later in 2026.