EUCTR2017-002063-17-IT进行中（未招募）1 期
A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC - ALERT-lung: ALEctinib for the treatment of pre-treated RET-rearranged advanced non-small cell lung c
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- •- Histologically or cytologically-documented non-small cell lung
- •- Advanced disease defined as recurrent stage IV (according to 8th TNM
- •classification) or recurrent or progressive disease following multimodal
- •therapy (radiation therapy, surgical
- •resection, or definitive chemo-radiation therapy for locally advanced
- •- RET rearrangement detected by FISH, Nanostring or by parallelsequencing
- •on FFPE tumour tissue (biopsy, resection or cytoblock)
- •assessed locally.
- •- Availability of FFPE tumour material for central confirmation of RETrearrangement
- •- At least one prior platinum-based systemic regimen: Adjuvant or
- •neoadjuvant or definitive platinum-based chemo-radiotherapy
- •treatments are considered as a line of treatment only if completed lesthan 6 months before enrolment. Maintenance therapy following
- •platinum doublet-based chemotherapy is not considered a separate
- •regimen of therapy.
- •- Measurable or non-measurable, but radiologically evaluable (except for
- •skin lesions) disease according to RECIST v1.1 criteria
- •- Adequate haematological, renal and liver function
- •- ECOG Performance Status 0-2
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- Untreated, active CNS metastases
- •- Carcinomatous meningitis
- •- Baseline symptomatic bradycardia
- •- Prior treatment with any RET TKI or RET targeted therapy
- •- Known EGFR, ALK, ROS, and BRAF mutation (in addition to RET
- •rearrangement)
- •- Any GI disorder that may affect absorption of oral medications, such as
- •malabsorption syndrome or status post-major bowel resection
- •- History of hypersensitivity to any of the additives in the alectinib drug
- •formulation
- •- Pregnant or lactating women
- •- Known HIV positivity or AIDS-related illness
- •- Any concurrent systemic anticancer therapy
研究者
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