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 - First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Amgen0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Key Inclusion Criteria:
•- Histologically or cytologically confirmed SCLC
•- Extensive disease, defined by at least one of the following criteria:
•- 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 non-measurable disease, as defined by modified RECIST
•- Eastern Cooperative Oncology Group (ECOG) performance 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 (HgbA1c) <= 8% and fasting blood glucose level <= 160 mg/dL

•Key Exclusion Criteria
•- Prior chemotherapy, chemo-radiation, or investigational agent for SCLC
•- Prior radiotherapy to > 25% of the bone marrow
•- Symptomatic or untreated central nervous system (CNS) metastasis (with exceptions)
•- Currently or previously treated with biological, immunological or other therapies for SCLC
•- Current serious or non-healing wound or ulcer
•- History of prior or concurrent other malignancy (with exceptions)
•- Any clinically significant medical condition other than cancer (eg, cardiovascular disease or chronic obstructive pulmonary disease), which could interfere with the safe delivery of study treatment or increase risk of toxicity
•- pregnancy or breast feeding

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