CTIS2023-508757-75-00
招募中
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) - CA209-9LA
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 Corporation
- 入组人数
- 840
- 状态
- 招募中
- 最后更新
- 去年
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 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)
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
结局指标
主要结局
未指定
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