EUCTR2014-003208-59-IT进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN - PACLITAXEL OR MPDL3280A IN COMBINATION WITH CARBOPLATIN- NAB PACLITAXEL VERSUS CARBOPLATIN - NAB-PACLITAXEL IN CHEMOTHERAPY NAÏVE PATIENTS WITH STAGE IV SQUAMOUS NON-SMALL CELL LUNG CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,021
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
- •ECOG performance status of 0 or 1
- •Histologically or cytologically confirmed, Stage IV squamous NSCLC
- •No prior treatment for Stage IV squamous NSCLC
- •Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI) appropriate for the treatment of EGFR-mutant NSCLC.
- •Patients with an ALK fusion oncogene must have experienced disease progression (during or after treatment) or intolerance to treatment with one or more ALK inhibitors (i.e. crizotinib) appropriate for the treatment of NSCLC in patients having an ALK fusion oncogene.
- •Patients who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy or completion of chemoradiotherapy.
- •Measurable disease, as defined by RECIST v1.1
- •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 720
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 480
排除标准
- •Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomization
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •Positive test for HIV
研究者
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