Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer

Inclusion Criteria:

- >18 years old

- Histologically or cytologically confirmed diagnosis of NSCLC

- Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients
who have received one prior platinum-based chemotherapy regimen

- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria

- ECOG performance status score of 0 or 1

- Willing and able to provide written informed consent

Exclusion Criteria:

- Laboratory values of:

- Absolute neutrophil count < 1500/ul;

- Platelet count < 75,000/ul;

- Hemoglobin < 10 gm/dl;

- AST or ALT > 3 x the upper limit of normal (ULN);

- Alkaline phosphatase > 5 x ULN;

- Bilirubin > 2 x ULN;

- Serum creatinine > 2.0 mg/dL.

- Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.

- Evidence of meningeal metastasis.

- Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant
cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).

- Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic
biologic anticancer therapy within 21 days before beginning study treatment.

- Significant weight loss > 10% of body weight in preceding 6 weeks.

- Treatment for another cancer within 3 years of enrollment, unless basal cell
carcinoma or cervical cancer in situ.

- Myocardial infarction within 6 months of enrollment or congestive heart failure rated
New York Heart Association (NYHA) Class III or IV.

- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood
pressure > 110 mm Hg on maximal medical therapy).

- Known history of porphyria (testing not required at screening visit).

- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not
required at screening visit).

- Known history of HIV infection (testing not required at screening visit).

- Female who is pregnant or lactating (serum pregnancy test is required for all female
patients of childbearing potential).

- Sexually active male or female of childbearing potential unwilling to use adequate
contraceptive protection.

- Physical or mental condition that makes patient unable to complete specified
follow-up assessments.