EUCTR2017-001195-35-IT
进行中（未招募）
1 期
A Phase 3, Randomized Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC) - CheckMate 9LA, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9LA
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Stage IV Non-Small Cell Lung Cancer (NSCLC)
- 发起方
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- 入组人数
- 840
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Women of childbearing potential (WOCBP) must have a negative serum
- •or urine pregnancy test \[minimum sensitivity 25 units per litre (IU/L) or
- •equivalent units of human chorionic gonadotropin (HCG)] within 24
- •hours prior to the start of study drug
- •\- WOCBP must agree to follow instructions for methods(s) of
- •contraception for the duration of treatment with nivolumab and 5
- •months after the last dose of nivolumab (ie 30 days \[duration of
- •ovulatory cycle] plus the time required for nivolumab to undergo
- •approximately five half\-lives)
- •\- Males who are sexually active with WOCBP must agree to follow
排除标准
- •\- Participants with known epidermal growth factor receptor (EGFR)
- •mutations which are sensitive to available targeted inhibitor therapy
- •(including, but not limited to, deletions in exon 19 and exon 21 \[L858R]
- •substitution mutations) are excluded
- •\- Participants with known anaplastic lymphoma kinase (ALK)
- •translocations which are sensitive to available targeted inhibitor therapy
- •are excluded
- •\- Participants with untreated CNS metastases are excluded. Participants
- •are eligible if CNS metastases are adequately treated and participants
- •are neurologically returned to baseline (except for residual signs or
结局指标
主要结局
未指定
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