A Phase I Study of GRN163L in Combination 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