Finding studies
Finding studies
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Lead
Shenzhen TargetRx Co., Ltd.
With
This Phase III study aims to evaluate the safety profile and efficacy profile in patients with ALK-positive advanced or metastatic NSCLC and to compare the efficacy and safety of TGRX-326 with that of crizotinib. The primary purpose of this study is to evaluate and compare the efficacy profile of TGRX-326 with crizotinib, with progression-free survival (PFS) as evaluated by independent review committee (IRC) as end point. Secondary objectives include comparing efficacy profile of other endpoints and safety profiles of the investigational drug with crizotinib. Exploratory objective includes the evaluation of population pharmacokinetic (PK) profile of TGRX-326 and efficacy of TGRX-326 in ALK-positive advanced NSCLC patients determined as progressive disease after crizotinib treatment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted