Phase II Study of Alectinib in Patients with Advanced Non-Small-Cell Lung Carcinoma harboring ALK Rearrangement detected by Liquid Biopsy

Department of Thoracic Oncology, National Cancer Center Hospital East0 个研究点目标入组 25 人开始时间: 2020年2月12日最近更新: 2023年10月17日

试验速览

暂无简介。

•Main Inclusion Criteria
•-Histologically- or cytologically-confirmed diagnosis of NSCLC.
•-Unresectable Stage III without any indications for radiotherapy StageIV or recurrence
•-At least one non-irradiated measurable lesions according to RECIST v1.1
•-Males and females age >= 20 years on the date of informed consent for study participation
•-An ECOG PS score of 0-2
•-Has adequate organ functions
•-Signed a written consent form after explanation of this study with documents.
•-Agree to effective contraception during the study and for at least 90 days after the last dose of alectinib.

•Main exclusion Criteria
•-History of ALK inhibitor administration
•-History of administration of immune checkpoint inhibitors.
•-Any prior treatment including chemotherapy, radiotherapy, and surgery within 2 weeks prior to enrollment
•-Has not recovered to grade 1 from acute toxicity of prior treatment
•-Symptomatic central nervous system metastasis
•- CT-confirmed or a history of interstitial fibrosis, pneumonitis or interstitial lung disease
•-Any of Myocardial infarction, severe or unstable angina, heart failure, etc. within 3 months prior to the start of study treatment
•-Ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade >= 2, uncontrolled atrial fibrillation of any grade, and QTc > 480 msec
•-Pregnancy or breastfeeding
•-Patients with a history of hypersensitivity to alectinib or alectinib vehicles

发起方

Department of Thoracic Oncology, National Cancer Center Hospital East