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