A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: CRLX101; Best Supportive Care
Intervention description: CRLX101 is administered at 15mg/m2 IV every other week; best supportive care
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare median overall survival of patients with advanced
      non-small cell lung cancer (NSCLC) treated with CRLX101 to patients treated with best
      supportive care (BSC).
    

Eligibility criteria:

        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 < 2 ×
             ULN, AST or ALT ≤ 2.5 × ULN or ≤ 5 × ULN for patients with liver metastasis, PTT
             within normal limits, INR ≤ 1.5, Serum Creatinine <1.5 ULN

          -  At least 4 weeks post any radiotherapy or biological therapy; at least 6 weeks post
             nitrosoureas therapy.

          -  Full recovery from diagnostic or therapeutic surgery (i.e., complete wound healing)
             and at least 30 days have elapsed prior to initial dosing.

          -  Full recovery from the toxic effects of prior therapy (i.e., Common Toxicity Criteria
             [CTC] Grade 1 or less with the exception of Grade 2 alopecia).

          -  Women of childbearing potential must have adequate pregnancy test. If postmenopausal,
             must be ≥ 12 months since last menses.

          -  Women of childbearing potential and men must agree to use an effective form of
             contraception during the study and for 60 days after the last dose of study drug.

        Exclusion Criteria:

          -  CNS metastases by radiologic evidence or histology, unless clinically stable (must
             have been treated by resection or radiation) for at least 4 weeks prior to first dose
             of study drug. Patients may not be receiving dexamethasone for control of CSF
             pressure.

          -  Concurrent therapeutic anticoagulation: PTT less than or equal to 1.5 × ULN or low
             dose aspirin and low-weight heparin only are allowed.

          -  More than 2 previous lines of chemotherapy for lung cancer. This includes biologic
             (immunotherapy) therapy.

          -  History of previous cerebrovascular accident (CVA) or history transient ischemic
             attack (TIA) within 6 months of study entry.

          -  History of prior malignancy not cured by excision. Patients with non-melanoma skin
             cancer or carcinoma in situ of the cervix are not excluded, but patients with other
             prior malignancies must have had at least 2-year disease free interval.

          -  Recent history (within 6 months of screening) of unstable angina, myocardial
             infarction, or NYHA Class III or IV congestive heart failure

          -  History of cardiac arrhythmia requiring medical or electrical therapy.

          -  QTc > 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.