A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

* Disease Related

  * Histologically or cytologically confirmed non-small cell lung cancer.
  * Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
  * Planning to receive up to 6 cycles of chemotherapy
  * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
  * Men or women \> 18 years of age Ethical
  * Adequate Hematological, renal, hepatic and coagulation function General
  * Plan to begin protocol specific therapy \< 7 days after enrollment/randomization

Exclusion Criteria:

* Disease Related

  * Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
  * Prior chemotherapy as follows:
  * Any prior chemotherapy for advanced non-small cell lung cancer
  * Any prior adjuvant chemotherapy for non-small cell lung cancer \< 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed \> 52 weeks prior to randomization is permitted.
  * Any prior chemoradiation.
  * Central (chest) radiation therapy \< 28 days prior to randomization, radiation therapy for peripheral lesions \< 14 days prior to enrollment/randomization
  * Other abnormal medical conditions
  * Documented myocardial infarction or unstable/uncontrolled cardiac condition
  * History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
  * Major surgical procedure \< 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure \< 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery