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

osaki Kaname0 个研究点目标入组 21 人开始时间: 2021年4月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Histologically- or cytologically-confirmed diagnosis of NSCLC.
•-Stage III , IV or postoperative recurrence with unresectable and incapable radical radiation therapy.
•-Liquid NGS analysis revealed that the RET fusion gene.
•-one or more 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 sufficient organ functions
•-The patient has signed a written consent form after receiving written information about the trial prior to enrollment

•-Participating in another trial and receiving treatment
•-History of RET inhibitor administration
•-Has not recovered to grade 1 from acute toxicity of prior treatment
•-Symptomatic central nervous system metastasis
•-CT-confirmed or a history of interstitial pulmonary fibrosis, pneumonitis or interstitial lung disease
•-Patients with poor control or clinically problematic heart disease, diagnosed at screening, or myocardial infarction within the past 6 months prior to Day 1.
•-Pregnancy or breastfeeding
•-Patients with a history of hypersensitivity to Selpelcatiinib or Selpelcatiinib vehicles
•-Patients who have been taking drug sthat have a strong inhibiting/inducing effect on CYP3A4, for at least 5 days before the intinal dose of the study drug.
•-Patients who have been taking drugs that may cause QTc prolongation for at least 5 days before the intinal dose of the study drug.
•-Patients who have been taking PPI for at least 7 days before the intinal dose of the study drug.

发起方

osaki Kaname