EUCTR2015-001537-24-SK进行中（未招募）1 期
A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum based doublet as a first line treatment of recurrent or Stage IV PD L1+ non small cell lung cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 1,131
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key inclusion criteria:
- •Male or female subjects = 18 years, with an ECOG PS of 0 to 1 at trial entry, with the availability of a formalin-fixed, paraffin-embedded block containing tumor tissue or 10 (preferably 25) unstained tumor slides with PD-L1+, at least 1 measurable tumor lesion, and with histologically confirmed metastatic or recurrent (Stage IV) NSCLC. Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks.
- •Other protocol defined criteria could apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 543
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 588
排除标准
- •Key exclusion criteria:
- •Subjects whose disease harbors a EFGR mutation or an anaplastic lymphoma kinase (ALK) rearrangement are not eligible. Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents, known severe hypersensitivity reactions to monoclonal antibodies (Grade = 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03. Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of =10mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
- •Other protocol defined criteria could apply
研究者
相似试验
进行中（未招募）
1 期
Avelumab* in First Line Non-Small Cell Lung Cancer*Avelumab is the proposed International Nonproprietary Name (INN) for the anti-PD-L1 monoclonal antibody (MSB0010718C)First Line Non-Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001537-24-NLMerck KGaA1,131
进行中（未招募）
1 期
Avelumab in First Line Non-Small Cell Lung CancerFirst Line Non-Small Cell Lung CancerMedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001537-24-CYMerck KGaA1,095
进行中（未招募）
1 期
Avelumab in First Line Non-Small Cell Lung CancerEUCTR2015-001537-24-DKMerck KGaA1,131
已完成
不适用
A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non–small-cell lung cancer-C34 Malignant neoplasm of bronchus and lungMalignant neoplasm of bronchus and lungC34PER-004-16Merck KGaA,8
进行中（未招募）
1 期
Avelumab* in First Line Non-Small Cell Lung CancerFirst Line Non-Small Cell Lung CancerMedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001537-24-BGMerck KGaA1,131