This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to explore the safety and PK characteristics of PLM60
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Administration: Intravenous infusion
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Objective response rate (ORR)
To evaluate ORR in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Duration of Response (DoR)
To evaluate DoR in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Disease Control Rate (DCR)
To evaluate DCR in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Progression Free Survival (PFS)
To evaluate PFS in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Overall Survival (OS)
To evaluate OS in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Adverse Events
To evaluate the safety profiles in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
Serious Adverse Events (SAEs)
To evaluate the safety profiles in SCLC subjects treated with PLM60
Time frame: Through study completion, an average of 2 year
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