Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

This is a multi-center, randomized study that will compare the efficacy of photodynamic
therapy (PDT) and argon plasma coagulation (APC) in the treatment of airway obstruction
caused by non small cell lung cancer. Participants will be randomized in a 1:1 ratio to
receive treatment with one of these two treatment modalities.

Inclusion Criteria:

- Written informed consent obtained from the subject or the subject's legal
representative and the ability for the subject to comply with all the study-related
procedures.

- Subjects must have a biopsy proven for non-small cell lung cancer with obstructing or
partially obstructing endobronchial tumor involving the main stem bronchus or bronchus
intermedius, with or without extrabronchial tumor.

- Both males and females ≥ eighteen years of age

- Subject must demonstrate at least a 50% airway stenosis due to endobronchial tumor.

- Subject must demonstrate symptoms of cough, hemoptysis, dyspnea etc. attributable to
partially or completely occluding endobronchial tumor.

- Subject is able to tolerate multiple bronchoscopies.

- Subjects who were previously treated with chemotherapy or radiotherapy are eligible
for study entry. Such subjects must be at least 3 weeks post-chemotherapy and/or
radiotherapy and must have recovered from all acute toxicities associated with such
treatment.

- A predicted life expectancy of at least 90 days.

Exclusion Criteria:

- Prior treatment of bronchogenic carcinoma with PDT or with APC.

- Subjects with tracheal lesions or carinal lesions that compromise both main stem
bronchi.

- Subjects who have undergone pneumonectomy.

- Tumor involving or eroding into major blood vessels.

- Presence of a tracheoesophageal or bronchoesophageal fistula.

- Subjects receiving concurrent systemic chemotherapy (excluding targeted therapies)
and/or concurrent external beam radiation therapy.

- Chemotherapy and/or radiation therapy within the previous three weeks.

- Inability to adhere to sunlight precautions.

- Severe hepatic impairment.

- Severe renal impairment.

- Porphyria or hypersensitivity to porphyrins.

- Subjects requiring supplemental O2 with a flow of greater than 3 lpm to keep resting
oxygen saturations greater than 90%.

- History of any other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of protocol therapy or that might affect the interpretation of
the results of the study or that puts the subject at high risk for treatment
complications, in the opinion of the treating physician.

- Prisoners or subjects who are involuntarily incarcerated.

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical illness.

- Subjects demonstrating an inability to comply with the study and/or follow-up
procedures.