AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
AK112 Monotherapy
Guangdong Provincial People's Hospital
Guangzhou, China
Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1.
Time frame: up to 2 years
Overall survival (OS)
From date of enrollment until the date of death from any cause
Time frame: up to 2 years
Progression-free survival (PFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Time frame: up to 2 years
Duration of response (DoR)
Duration of response (DoR), which 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 2 years
Disease control rate (DCR)
Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1
Time frame: up to 2 years
Time to response (TTR)
TTR is defined as the time to response base on RECIST v1.1
Time frame: up to 2 years
Percentage of participants with adverse event (AE)
The percentage of participants experiencing an adverse event (AE) and the severity of AEs will be assessed
Time frame: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years
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Observed concentrations of AK112
The endpoints for assessment of Pharmacokinetics (PK) of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration
Time frame: From date of enrollment until the end of treatment, assessed up to 2 years
Number of participants who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK112 will be assessed by summarizing the number of participants who develop detectable antidrug antibodies (ADAs)
Time frame: From first dose of AK112 through 90 days after last dose of AK112,up to 2 years
Number of participants with programmed cell death ligand 1 (PD-L1) expression positive who achieve CR/PR
Time frame: From date of enrollment until the end of treatment, assessed up to 2 years