Endobronchial Ultrasound Guided Interstitial Photodynamic Therapy in Treating Patients With Locally Advanced Lung Cancer

PRIMARY OBJECTIVES:

I. To evaluate the safety of endobronchial ultrasound bronchoscopy (EBUS)-transbronchial
needle (TBN) guided interstitial photodynamic therapy (I-PDT) in patients with locally
advanced lung cancer (LALC) in the central airway, using porfimer sodium as a
photosensitizer.

SECONDARY OBJECTIVES:

I. To assess the tumor response to treatment. II. To evaluate progression-free survival
(PFS).

EXPLORATORY OBJECTIVES:

I. Examine porfimer sodium retention in the target tumor tissue. II. Examine the relationship
between immune biomarkers and response.

OUTLINE:

Patients receive Porfimer sodium intravenously (IV) over 20 minutes 2-4 hours prior to the
delivery of I-PDT. Patients then undergo EBUS-TBN guided I-PDT over 30-45 minutes.

After completion of study treatment, patients are followed up at 4, 8, 12, and 24 weeks.

Inclusion Criteria:

- Eligibility checklist before registration requires review of case by study surgeon or
interventional pulmonologists to approve anatomic feasibility of an airway
intervention

- Patients with an established pathologic diagnosis of non-small cell lung cancer with
airway obstruction > 25% requiring bronchoscopic intervention.

- Patients with documented progressive central lung cancer despite chemo immune or
radiation therapy.

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 3.

- Platelets >= 100,000 cells/mm^3 (International System of Units [SI] units 100 x
10^9/L).

- International normalized ratio (INR) < 1.5 and Partial thromboplastin time (PTT) < 1.5
x upper limit of normal (ULN).

- Participants of child-bearing potential must agree to use adequate contraceptive
methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study
entry. Should a woman become pregnant or suspect she is pregnant while she or her
partner is participating in this study, she should inform her treating physician
immediately.

- Participant or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

- Participants who have had radiotherapy to the target tumor within 4 weeks prior to
entering the study

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant or nursing female participants.

- Co-existing ophthalmic disease likely to require slit-lamp examination within 14 days
following I-PDT treatment.

- Known hypersensitivity/allergy to porphyrin.

- Creatine clearance (CrCl) < 60 mL/min by Cockcroft Gault Equation.

- Patients who are not cleared by the anesthesiologist to undergo an advanced
bronchoscopy procedure under general anesthesia.

- Patients diagnosed with porphyria.

- Unwilling or unable to follow protocol requirements.

- Any condition which in the Investigator's opinion deems the participant an unsuitable
candidate to receive study drug.