This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Chinese PLA General Hospital
Beijing, China
Progression-free survival (PFS) in intent-to-treat (ITT) population, assessed by Independent Radiologist Review Committee(IRRC) in accordance with RECIST v1.1
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 IRRC or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
PFS in PD-L1-selected population, assessed by IRRC in accordance with RECIST v1.1
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 IRRC or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
Overall survival (OS) in ITT population
OS is the time from the date of randomization to death due to any cause.
Time frame: Up to approximately 2 years
Overall survival (OS) in PD-L1-selected population
OS is the time from the date of randomization to death due to any cause.
Time frame: Up to approximately 2 years
PFS assessed by the investigator in accordance with RECIST v1.1
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 investigator or death due to any cause (whichever occurs first).
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
ORR is the proportion of subjects with CR or PR , based on RECIST v1.1.
Time frame: Up to approximately 2 years
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IV infusion
Duration of response (DoR)
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Time frame: Up to approximately 2 years
Incidence and severity of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence or the deterioration of existing medical event in a clinical study subject administered an investigational drug, which does not necessarily have an unequivocal causal relationship with the investigational product.
Time frame: From the time of informed consent signed through 90 days after last dose of AK105
Observed concentrations of AK105
The endpoints for assessment of PK of AK105 include serum concentrations of AK105 at different timepoints after AK105 administration.
Time frame: From first dose of AK105 through 90 days after last dose of AK105
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).
Time frame: From first dose of AK105 through 90 days after last dose of AK105