A phase II study of Lorlatinib in ROS1-rearranged advanced NSCLC

ational Cancer Center0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年3月4日

试验速览

暂无简介。

•1)Metastatic or recurrent NSCLC with ROS1 rearrangement identified by NGS-based target sequencing
•2)Treatment naïve or one prior systemic treatment with platinum doublet chemotherapy
•3)At least one measurable disease lesion according to RECIST 1.1
•4)ECOG performance status 0-2
•5)Age = 18 years
•6)Adequate hematologic, hepatic, and renal function
•a. Absolute Neutrophil Count (ANC) = 1,500/mm3 or = 1.5 x 109/L;
•b. Platelets =100,000/mm3 or =100 x 109/L;
•c. Hemoglobin = 9 g/dL.
•d. Serum total amylase = 1.5 x upper limit of normal (ULN)
•*if total amylase > 1.5 x ULN, but pancreatic amylase is within the ULN, then patient may be enrolled
•e. Serum lipase = 1.5 x ULN.
•f. Serum creatinine = 1.5 x ULN or estimated creatinine clearance = 60 mL/min as calculated using the method standard for the institution
•g. Total serum bilirubin = 1.5 x ULN;
•h. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) = 2.5 x ULN (= 5.0 x ULN in case of liver metastases).
•7)Written informed consent

•1)Life expectancy of less than 12 weeks
•2)Prior treatment with ROS1 inhibitor
•3)Symptomatic uncontrolled brain metastasis
•4)Other malignancy within 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
•5)Uncontrolled intercurrent illness
•6)Pregnancy or unwillingness to use effective birth control

发起方

ational Cancer Center