This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
Sun Yat-Sen University Cancer Center
Guanzhou, Guangdong, China
ORR
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Time frame: Up to approximately 2 years
PFS
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
OS
OS is the time from the date of randomization or first dosing date to death due to any cause.
Time frame: Up to approximately 2 years
Disease control rate
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
Time frame: Up to approximately 2 years
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IV infusion
IV infusion