The aim of this study was to investigate the safety and efficacy of Sintilimab (IBI308) in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with stage II-IIIA NSCLC
Sintilimab injection (IBI308) as neoadjuvant therapy in patients with resectable NSCLC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Sintilimab injection 200mg, 2cycles of treatment before surgery
Major pathologic response rate(MPR)(<10% viable tumor cells)
To assess the major pathologic response rate (\<10% viable tumor cells) in patients receiving Sintilimab Injection
Time frame: At time of surgery
Disease Control Rate (DCR)
the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.
Time frame: up to 2 years
Overall response rate (ORR)
the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
Time frame: up to 2 years
Disease-free survival (DFS)
Defined as the time from date of surgery until recurrence of tumor or death from any cause
Time frame: up to 2 years
Incidence of irAEs
Immune-related AE per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Time frame: up to 2 years
Incidence of SAEs
Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)
Time frame: up to 2 years
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