A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Male or female patients who are ≥ 18-years of age.
• Histologically or cytologically confirmed, locally advanced or metastatic NSCLC (adenocarcinoma, bronchoalveolar, squamous cell, large cell, or mixed carcinoma) that is not amendable to surgical treatment and patient has have failed 1 or 2 different lines of chemotherapy.
• Measureable disease and evidence of progression on the previous therapy. Progression may be clinical or radiological.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Hemoglobin ≥ 10 g/dL.
• Absolute neutrophil count (ANC) ≥ 1500 cells/µL without growth factor support.
• Platelet count ≥ 100, 000 cells/µL without support.
• Adequate hepatic and renal function including the following: Total bilirubin 450 msec for males and > 470 msec for females.
• Any major surgery within 30 days or minor surgery within 10 days of study entry, or patient not recovered from surgery.
• History of organ or bone marrow transplant.
• Known active and/or uncontrolled infection, including HIV and are not stable on antiretroviral therapy.
• Any investigational therapy within 28 days of study entry.
• Pregnant or nursing.
• Anyone who in the judgment of the investigator cannot comply with the protocol, provide truly informed consent, or is likely to live < 90 days
• Severe or significant allergy to any chemotherapy or premedication.
• Clinically evident ascites (e.g., abdominal distention, bulging and/or fluid wave) or Grade 3 peripheral edema.
• Any prior cancer treatment with a topoisomerase I inhibitor.