Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Inclusion Criteria:

- All patients, 18 years of age or older, with resectable lung cancer (any stage) or
stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma, who have
failed standard chemotherapy or radiotherapy for their disease or who refuse standard
therapy are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of >1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

- Patients must not have a known symptomatic respiratory disease other than cancer, and
must have a pulmonary function test equal to >50% FEV1, >50% FEV1/FVC, >50% TLC, and
>50% DLCO of predicted values.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Any criteria that is borderline and may lead to ineligibility will be reviewed by the
PI, who may override the eligibility criteria, after receiving sponsor agreement, if
entry into the study is deemed to potentially benefit the patient.