QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

QUILT-2.013 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

This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.

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