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.