A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC - ALERT-lung

ETOP (European Thoracic Oncology Platform)0 个研究点目标入组 44 人开始时间: 2018年8月16日最近更新: 2021年4月12日

试验速览

暂无简介。

•- Histologically or cytologically-documented non-small cell lung carcinoma
•- 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 disease)
•- RET rearrangement detected by FISH, Nanostring or by parallel-sequencing on FFPE tumour tissue (biopsy, resection or cytoblock) assessed locally.
•- Availability of FFPE tumour material for central confirmation of RET-rearrangement
•- 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 less than 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 44
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 44

•- 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

发起方

ETOP (European Thoracic Oncology Platform)