This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous 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 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
532
IV infusion,Specified dose on specified days
IV infusion,Specified dose on specified days
Shanghai Chest Hospital
Shanghai, China
PFS assessed by IRRC per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
OS
Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause.
Time frame: Up to approximately 2 years
ORR assessed by IRRC per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame: Up to approximately 2 years
DoR assessed by IRRC per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1
Time frame: Up to approximately 2 years
DCR assessed by IRRC per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
TTR assessed by IRRC per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time frame: Up to approximately 2 years
PFS assessed by investigator per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
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Time frame: Up to approximately 2 years
ORR assessed by the investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1.
Time frame: Up to approximately 2 years
DoR assessed by the investigator per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
DCR assessed by the investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
TTR assessed by the investigator per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time frame: Up to approximately 2 years
AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to approximately 2 years
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to approximately 2 years
Cmax and Cmin
AK112 serum drug concentrations in subjects at different time points after AK112 administration
Time frame: Up to approximately 2 years
PD-L1 expression
The correlationship between PD-L1 expression and efficacy.
Time frame: Up to approximately 2 years