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
- 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
- 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
- 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