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
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
- 840
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
- •- 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
- •instructions for method(s) of contraception for the duration of treatment
- •with nivolumab and up to 7 months after the last dose of nivolumab (ie
- •90 days [duration of sperm turnover] plus the time required for
- •nivolumab to undergo approximately five half-lives)
- •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 546
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 294
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
- •symptoms related to the CNS treatment) for at least 2 weeks prior to
- •first treatment
- •Other protocol inclusion/exclusion criteria may apply
研究者
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