Spots Global Cancer Trial Database for Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
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Trial Identification
Brief Title: Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
Official Title: A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)
Study ID: NCT06128837
Conditions
Study Description
Brief Summary: This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)
Detailed Description: A multicenter, randomized, open-label, parallel study was designed to evaluate the efficacy and safety of LY01610 versus topotecan in the second-line treatment of patients with recurrent SCLC who were diagnosed by histopathology and/or cytology and had disease progression after first-line platinum-based chemotherapy, to conduct a population pharmacokinetics (PopPk) study, and to explore the effect of genetic polymorphisms on the pharmacokinetics properties, efficacy and safety of this product.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Contact Details
Name: yuankai shi, doctor
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
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