Clinical trial · Interventional
Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No participants were enrolled
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of I-PDT with Temoporfin for patients with Non-Resectable Non-Small-Cell Lung Cancer (NR-NSCLC). Several clinical studies suggested that photodynamic therapy (PDT) may be an effective treatment for patients with NR-NSCLC. PDT is a therapy where an external light source, such as laser, is used to activate a light-sensitive medicine to produce byproducts that can destroy cancer cells. In this study the investigators will use an experimental light sensitive medicine, Temoporfin, to perform interstitial PDT (I-PDT). In I-PDT, laser fibers are inserted into the tumor to activate the light-sensitive medicine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell-Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temoporfin | Drug | Temoporfin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Occurrence of serious adverse events
- timeFrame
- 14 and 30 days post-therapy
- description
- The specific aim of this pilot study is to evaluate the safety of CT-guided I-PDT with Temoporfin on patients with NR-NSCLC. Patient safety will be the primary endpoint. The safety of the intervention will be assessed at 14 and 30 days post-therapy. The primary outcome will be occurrence of Serious Adverse Events (SAE).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eighteen years of age and older, male or female, of all races and ethnicities. * Histologically confirmed non-small-cell lung cancer (NSCLC). * Not a candidate for curative surgery. * Not a candidate for curative concurrent chemoradiation therapy. * Not a candidate or does not wish to receive curative radiation therapy. * Not a candidate or does not wish to receive radiofrequency or microwave thermal ablation. * Have an Eastern Cooperative Oncology Group (ECOG) performance status \< 2. * The tumor is observable in CT with contrast. * The tumor is accessible for unrestricted illumination of interstitial photodynamic therapy (I-PDT). * Deemed likely to survive for at least 3 months. * Patient is able and willing to provide written informed consent to participate in the study. * If the subject is a female of childbearing potential, the subject is willing to take a pregnancy test and practice strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after Temoporfin administration. Women who have had a hysterectomy are exempt from these requirements. * Subject is willing to remain in a controlled light exposure environment for a time period of at least 15 days. * History of laboratory tests that meet the following criteria * Hematocrit \>= 33%, hemoglobin \>= 11 g/dl * Platelet count \> 70,000 per microliter * White blood count \> 3,000 per microliter or ANC \> 1500 per microliter * Creatinine: 0.8 to 1.4 mg/dL * Serum chloride: 101 to 111 mmol/L * Serum potassium: 3.7 to 5.2 mEq/L * Serum sodium: 136 to 144 mEq/L * Liver function test: albumin, bilirubin (direct/conjugated), ALT (alanine transaminase), AST (aspartate transaminade), GGT (gamma glutamyl transferase), ALP (alkaline phosphatase) within normal limits * BUN: 7 to 20 mg/dL Exclusion Criteria: * The tumor invades a major blood vessel. * The tumor is not clearly shown on the CT image. * The tumor size is larger than 5 cm when measured in a contrasted CT image according to RECIST v1.1. * The location and extension of the tumor precludes an effective I-PDT. * Patient with porphyria or other diseases exacerbated by light. * Patient with hypersensitivity to Temoporfin or to any of its excipients. * Patient with known allergies/hypersensitivity to porphyrins. * Patient with a planned surgical procedure within the next 30 days. * Patient with a coexisting ophthalmic disease likely to require slit-lamp examination within the next 30 days. * Patient with existing therapy with a photosensitizing agent (Temoporfin, porphyrin or derivatives of porphyrin). * Patient has received prior PDT to the proposed treatment site within the prior 3 months. * Patient with known sensitivity to the CT contrast agent (Omnipaque), which would preclude the use of the CT contrast agent. * History of poor renal function as demonstrated by serum creatinine and estimated glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2, which would preclude the using of the CT contrast agent.
References
Publications (0)
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