Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of NSCLC
Stage IIIb with pleural effusion, Stage IV, or recurrent disease
Measurable or evaluable disease by RECIST criteria
ECOG performance status 0-1
Adequate hepatic/renal function and platelet count
If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%

Exclusion Criteria:

More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant chemotherapy is allowed)
Tumor progression during treatment with paclitaxel (refractory to paclitaxel)
Taxane-based regimen within 12 weeks
Any systemic therapy for cancer within 4 weeks
Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy
Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth per day)
Radiation therapy within 3 weeks
Major surgery within 4 weeks (central line placement is allowed)
Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
History of or active central nervous system metastatic disease
Any other active malignancy
Active or chronically recurrent bleeding (eg, active peptic ulcer disease)
Clinically significant infection
Active autoimmune disease requiring immunosuppressive therapy
Clinically significant cardiovascular disease or condition