This study is a randomized, open-label Phase 2 study to compare the efficacy and safety of IBI363 Combined with Chemotherapy or Pembrolizumab Combined with Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
RECRUITINGPathologic Complete Response (pCR) rate
pCR rate is defined as no residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Safety parameters: the incidence of all adverse events (AEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of treatment-emergent adverse events (TEAEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of immune-related adverse events (irAEs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of adverse events of special interest (AESIs)
Time frame: up to 90 days after the last dose
Safety parameters: the incidence of serious adverse events (SAE)
Time frame: up to 90 days after the last dose
Safety parameters: the relatedness of infusion-related reactions (IRRs) to the investigational product and their severity
Time frame: up to 90 days after the last dose
Safety parameters: the surgery delay rate
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Proportion of subjects with abnormal and clinically significant results including routine blood tests, blood biochemical tests, coagulation tests,, routine urine tests, pregnancy tests,ECG, etc
Time frame: up to 90 days after the last dose
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AUC 5 mg/ml/min D1 IV Q3W
200mg D1 IV Q3W
Event Free Survival (EFS)
EFS is defined as the time from the first dose to the first determination by the investigator with RECIST v1.1 of inoperable disease progression, postoperative local recurrence or distant metastasis, development of another primary tumor, or death from any cause, whichever occurred first.
Time frame: Up to approximately 5 years
Major Pathological Response (mPR) Rate
mPR rate is defined as ≤ 10% residual invasive viable tumor in both the primary tumor (lung) and the sampled lymph nodes after neoadjuvant therapy.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Objective Response Rate (ORR)Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) or partial response (PR) according to the RECIST v1.1 criteria.
Time frame: Up to approximately 5 years
Disease Control Rate (DCR) Rate
ORR is defined as the proportion of subjects assessed by the investigators as achieving complete response (CR) 、partial response (PR) or stable Disease(SD) according to the RECIST v1.1 criteria.
Time frame: Up to approximately 5 years
R0 resection rate
R0 resection rate is defined as negative margins, systematic lymph node dissection or sampling, and tumor-negative highest mediastinal lymph nodes.
Time frame: Up to approximately 8 weeks following completion of neoadjuvant treatment