Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
Number of patients with Adverse Events (AEs)
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DOR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) Of AK104
Time frame: Up to approximately 2 years
Antidrug antibodies (ADA) of AK104
Time frame: Up to approximately 2 years
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