This trial is a Phase Ib/II study. All patients are stage IIIB/C (unsuitable for radical therapy) 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 safety and efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
Subjects receive AK112 intravenously.
Subjects receive AK104 intravenously.
Subjects receive carboplatin intravenously.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, China
RECRUITINGSafety reflected by AE
Safety will be reflected by AE, which 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 2 approximately years
ORR 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 2 approximately 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 2 approximately years
DoR per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
DCR per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to 2 approximately years
TTR per RECIST v1.1
Time to response (TTR) is defined as the time to response base on RECIST v1.1.
Time frame: Up to 2 approximately years
PFS per RECIST v1.1
Progression-free survival (PFS) is defined as the time from the date of Initial administration till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first).
Time frame: Up to 2 approximately years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subjects receive paclitaxel intravenously.
Subjects receive pemetrexed intravenously.
Subjects receive docetaxel intravenously.
AK112 serum concentration
The serum concentration of AK112 of individual subjects at different time points.
Time frame: Up to 2 approximately years
AK104 serum concentration
The serum concentration of AK104 of individual subjects at different time points.
Time frame: Up to 2 approximately years
ADA
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to 2 approximately years
PD-L1 expression
The correlationship between PD-L1 expression and efficacy.
Time frame: Up to 2 approximately years
ctDNA
The correlationship between ctDNA detection and efficacy.
Time frame: Up to 2 approximately years