To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
a multi-target protein kinase inhibitor.
a multi-target protein kinase inhibitor.
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: up to 36 months
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time frame: up to 36 months
Disease Control rate (DCR)
Percentage of subjects achieving CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD)
Time frame: up to 36 months
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 36 months
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