Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have
the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic
technologies (such as navigational bronchoscopy) have shown to enable physicians to safely
reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may
now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy,
to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is
activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits
no heat. This technique works to allow the medical doctor to specifically target and destroy
abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation
of the drug is done by lighting the abnormal area using a fiber optic device (very fine fiber
[like a fishing line] that permits light transmission) inserted into a flexible tube called
bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal
tissue, leading to its destruction.

The purpose of this study is to determine if physicians can reach the tumors in the periphery
of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by
placing the optical fiber into the tumor.

Inclusion Criteria:

- Male or female aged 18 or older

- Diagnosed with histologically confirmed solid tumor located in the peripheral lung

- Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo
curative surgery

- May be candidate for, have failed, or does not wish to undergo radiation therapy

- The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT
scan)

- Able to sign an informed consent

Exclusion Criteria:

- Diagnostic of small cell lung cancer

- Solid tumor located in central lung

- Presence of concurrent non-solid malignancy

- Abnormal blood results

- Received chemotherapy/immunotherapy in the last 4 weeks

- Tumor invades a major blood vessel

- Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to
any of its excipients

- Planned surgical procedure within the next 90 days

- Coexisting ophthalmic disease likely to require slit-lamp examination within the next
90 days

- Acute or chronic medical or psychological illnesses that prevent endoscopy procedures

- Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during
the study

- Received PDT during the past 3 months

- Severe impairment of your kidney or liver function

- Participates or intends to participate in another drug study (other than observational
studies) during the study