NL-OMON47780已完成3 期
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUNAB (MPDL3280A, ANTI*PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN + PACLITAXEL + BEVACIZUMAB IN CHEMOTHERAPY-NAiVE<br>PATIENTS WITH STAGE IV NON-SQUAMOUS NON*SMALL CELL LUNG CANCER. - GO29436
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- histologically or cytologically confirmed, Stage IV non-squamous NSCLC (per
- •the Union Internationale contre le Cancer/American Joint Committee on Cancer
- •staging system, 7th edition; Detterbeck et al. 2009). Patients with tumors of
- •mixed histology (i.e., squamous and nonsquamous) are eligible if the major
- •histological component appears to be non-squamous.
- •- adequate hematologic and end organ function, defined by the following
- •laboratory results obtained within 14 days prior to randomization.
- •- measurable disease, as defined by RECIST v1.1
排除标准
- •- active or untreated CNS metastases as determined by CT or MRI evaluation
- •during screening and prior radiographic assessments.
- •- any approved anti-cancer therapy, including chemotherapy, or hormonal therapy
- •within 3 weeks prior to initiation of study treatment; the following exceptions
- •are allowed:
- •* hormone-replacement therapy or oral contraceptives
- •* TKIs approved for treatment of NSCLC discontinued > 7 days prior to
- •randomization; the baseline scan must be obtained after discontinuation of
- •prior TKIs.
- •- women who are pregnant, lactating, or intending to become pregnant during the
- •- history of severe allergic, anaphylactic, or other hypersensitivity reactions
- •to chimeric or humanized antibodies or fusion proteins.
研究者
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