Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer

The goal of this trial is to demonstrate the potential clinical benefit of targeted
irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is
associated with increased sensitivity to this drug, ISG15H.

Inclusion Criteria:

-INCLUSION:

18 years of age or older Have received prior chemotherapy for histologically proven
advanced non-small cell lung cancer, up to 3 prior treatments Tumors display high ISG15
(ISG15H) at screening Life expectancy of at least 12 weeks ECOG/Zubrod performance status
of 0-2 Provide informed consent permission to participate

Adequate bone marrow function as follows:

1. Absolute neutrophil count of greater than or equal to 1,500 or cells/mm3, and 2)
Platelet count greater than or equal to 100,000/mm3 and 3) Absence of a regular red blood
cell transfusion requirement

Adequate hepatic function with:

1. Total bilirubin less than or equal to 4.0 mg/dl, and

2. SGOT or SGPT less than or equal to four times ULN

Adequate renal function as defined by:

1) Serum creatinine less than or equal to 1.5 x ULN

Exclusion Criteria:

Symptomatic brain metastases

Pregnant women or nursing mothers

Patients of child bearing potential must use adequate contraception.

May not be receiving other concurrent chemotherapy or radiation therapy

Severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or
active infections

Previous hypersensitivity reaction to camptothecins