AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC
Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Incidence and severity of adverse events (AE)
Summary of AE incidence; summary after grading of AE according to NCI CTCAE version 5.0
Time frame: Up to approximately 2 years
Rate of surgical delays
Proportion of subjects exceeding the maximum surgical time window
Time frame: Up to approximately 2 years
Abnormal laboratory findings of clinical significance
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests, thyroid function tests, routine urine tests, pregnancy tests, etc.
Time frame: Up to approximately 2 years
MPR
Proportion of subjects with ≤10% residual live tumor cells in resected primary tumor foci and lymph nodes
Time frame: Up to approximately 2 years
R0 resection rate
Proportion of subjects with pathologically complete resection of primary tumors
Time frame: Up to approximately 2 years
Tumor descending stage rate
Proportion of subjects with the most recent tumor staging prior to surgery (using TNM staging version 8) who were down-staged relative to baseline
Time frame: Up to approximately 2 years
pCR
Proportion of subjects with no residual tumor in the resected tumor primary and lymph nodes
Time frame: Up to approximately 2 years
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IV infusion
OS
Time from first dose until death from any cause
Time frame: Up to approximately 2 years
EFS
Time from first dose to the occurrence of any of the following events, whichever occurs first: disease progression, local recurrence or distant metastasis or death from any cause, as assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
ORR
ORR is the proportion of subjects with CR or PR,based on recist v1.1
Time frame: Up to approximately 2 years