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