Amgen Protocol 20060534 - A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
Inclusion Criteria
Key Inclusion Criteria
- Histologically or cytologically confirmed SCLC
- Extensive disease, defined by at least one of the following:
- No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can
be safely encompassed within a tolerable radiation field)
- Extrathoracic metastases
- Malignant pericardial or pleural effusion
- Contralateral hilar adenopathy
- Measurable or nonmeasurable disease, as defined by modified RECIST
- Eastern Cooperative Oncology Group (ECOG) status 0 or 1
- ≥18 years old
- Life expectancy (with therapy) ≥3 months
- Adequate hematologic, hepatic, coagulation, renal, and metabolic function
- Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8%
and fasting glucose levels ≤160 mg/dL
Key Exclusion Criteria
- Prior chemotherapy, chemoradiation, or investigational agent for SCLC
- Prior radiotherapy to >25% of the bone marrow
- Symptomatic or untreated central nervous system metastases (with exceptions)
- Currently or previously treated with biologic, immunologic or other therapies for
SCLC
- Current serious or nonhealing wound or ulcer
- History of prior concurrent other malignancy (with exceptions)
- Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE,
TIA or MI
- Any clinically significant medical condition other than cancer (eg, cardiovascular
disease or COPD), which could interfere with the safe delivery of study treatment or
risk of toxicity