CTIS2022-502658-15-00进行中(未招募)1 期
A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer (CheckMate 77T, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 77T) - CA209-77T
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 750
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 65+(—)
- 性别
- All
入选标准
- •Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable, No brain metastasis, Treatment-naive for NSCLC (no prior systemic anti-cancer treatment), Ability to provide surgical or biopsy tumor tissue for biomarkers, Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1
排除标准
- •Participants with an active, known or suspected autoimmune disease, Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV), Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC, Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti- CTLA-4 antibody, or any other antibody or drug specifically targeting Tcell co stimulation or checkpoint pathways
研究者
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