Photodynamic Therapy (PDT) With Temoporfin for Non-Resectable Non-Small-Cell Lung Cancer
- 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
- 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
- Deemed likely to survive for at least 3 months.
- Patient is able and willing to provide written informed consent to participate in the
- 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
- 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
- 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
- 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.