JPRN-jRCT2080223248已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin plus Etoposide with or without Atezolizumab (Anti-PD-L1 Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 403
研究概览
简要总结
The addition of atezolizumab to carboplatin and etoposide was associated with significantly longer overall survival and progression-free survival among patients with ES-SCLC, and the safety profile of ACE was consistent with the defined safety risks of the individual agents.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed ES-SCLC
- •-No prior treatment for ES-SCLC
- •-ECOG performance status of 0 or 1
- •-Measurable disease, as defined by RECIST v1.1
- •-Adequate hematologic and end organ function
排除标准
- •-Active or untreated CNS metastases
- •-Malignancies other than SCLC within the last 5 years
- •-Pregnant or lactating women
- •-History of autoimmune disease
- •-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •-Positive test for Human Immunodeficiency Virus (HIV)
- •-Active hepatitis B or hepatitis C
- •-Severe infections at the time of enrollment
- •-Significant cardiovascular disease
- •-Prior treatment with cluster of CD137 agonists or immune checkpoint blockade therapies, anti-PD1, and anti-PD-L1 therapeutic antibody
研究者
相似试验
已完成
3 期
A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Canceron-Small Cell Lung CancerJPRN-jRCT2080222890CHUGAI PHARMACEUTICAL CO., LTD1,202
已完成
3 期
A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-paclitaxel Compared With Carboplatin + Nab-paclitaxel in Patients With Stage IV Squamous NSCLCon-Small Cell Lung CancerJPRN-jRCT2080222847Chugai Pharmaceutical Co., Ltd.1,021
已完成
3 期
A Comparative Study of atezolizumab(MPDL3280A)With standard chemotherapy in Patients With Stage IV NSCLCon-Small Cell Lung CancerJPRN-jRCT2080222849Chugai Pharmaceutical Co., Ltd.572
已完成
3 期
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast CancerTriple Negative Breast NeoplasmsNCT03371017Hoffmann-La Roche595
已完成
3 期
A Phase III Study of atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer [IMpower132]JPRN-jRCT2080223142CHUGAI PHARMACEUTICAL CO., LTD.578