Study of Motexafin Gadolinium (MGd) 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.