NCT06939595进行中（未招募）3 期
A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celltrion
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
研究概览
简要总结
The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage IV, non squamous NSCLC
- •Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
- •Have at least 1 measurable lesion per RECIST version 1.1
排除标准
- •Have predominantly squamous cell histology NSCLC.
- •Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin
研究组 & 干预措施
EU-approved Keytruda
Active Comparator
干预措施: EU-approved Keytruda (Drug)
CT-P51
Experimental
干预措施: CT-P51 (Drug)
结局指标
主要结局
ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
时间窗: Up to 34 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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