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