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.