To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.
Sun-Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGObjective Response Rate (ORR)
The percentage of participants with a best overall response defined as complete response (CR) or partial response (PR).
Time frame: up to 36 months
Progression-free survival (PFS)
The time from randomization to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
Time frame: up to 36 months
Disease control rate (DCR)
Calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
Time frame: up to 36 months
Overall survival (OS)
Time from date of randomization to date of death due to any cause.
Time frame: up to 36 months
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