NCT02109653撤回2 期
A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy
Array Biopharma, now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Presence of BRAF V600E mutation in tumor tissue
- •Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
- •At least one measurable lesion as defined by RECIST v1.1
- •Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
- •Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2
排除标准
- •Patients with symptomatic Central Nervous System (CNS) metastases
- •History of leptomeningeal metastases
- •Prior therapy with a BRAF inhibitor
- •Patients taking prohibited medication listed in the protocol
- •Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
- •Impaired cardiovascular function or clinically significant cardiovascular diseases
- •Pregnant or lactating women or woman of childbearing potential
研究组 & 干预措施
LGX818
Experimental
Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.
干预措施: LGX818 (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to 24 weeks
ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
次要结局
- Overall survival (OS)(baseline, every 6 weeks up to 24 weeks)
- Overall Response Rate (ORR)(baseline, every 6 weeks up to 24 weeks)
- Progression-Free Survival (PFS)(baseline, every 6 weeks up to 24 weeks)
- Duration of Response (DOR)(baseline, every 6 weeks up to 24 weeks)
- Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay(screening, up to 24 weeks)
- Safety Profile(baseline, every 3 weeks up to 24 weeks)
- Disease Control Rate (DCR)(baseline, every 6 weeks up to 24 weeks)
- Pharmacokinetics profile(baseline, every 3 weeks up to 18 weeks)
研究者
研究点 (1)
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