The main purpose of this study is to evaluate the neoadjuvant therapy efficacy of IBI110 in combination with sintilimab versus sintilimab alone based on pathologic complete response (pCR) rate in stage IIB (primary tumor \> 4 cm ) to IIIB (N2 only) subjects with radically resectable NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
R2PD d1 IV every 3 weeks
200mg d1 IV every 3 weeks
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
pCR
defined as having no residual visible tumor cells in the surgically resected primary tumor and lymph node samples (ypT0N0)
Time frame: Approximately 21 to 28 days after operation
Incidence of serious adverse events (SAEs), treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs)
An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is an important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. A TEAE will be defined as any new AE that begins, or any pre-existing condition that worsens in severity, after at least 1 dose of study treatment has been administered. irAEs will be assessed.
Time frame: up to 90 days after the last administration
Number of participants with abnormality in vital signs
Blood pressure, pulse, respiratory rate, and temperature will be assessed.
Time frame: up to 90 days after the last administration
Number of participants with abnormality in hematology parameters
Blood samples will be collected to evaluate hemoglobin, mean corpuscular volume (MCV), white blood cell (WBC) count, platelets, 5-part differential white cell count, mean platelet volume and coagulation factors including international normalized ratio (INR), activated partial thromboplastin time (aPTT) and prothrombin time (PT).
Time frame: up to 90 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or blood urea nitrogen (BUN), bicarbonate, amylase, bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, albumin, lactate dehydrogenase and lipase.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 90 days after the last administration
Number of participants with abnormality in clinical chemistry parameters
Blood samples will be collected to evaluate sodium, potassium, calcium, magnesium, chloride, glucose, creatinine, urea or BUN, bicarbonate, amylase, bilirubin, alkaline phosphatase, AST, ALT, total protein, albumin, lactate dehydrogenase and lipase.
Time frame: up to 90 days after the last administration
Number of participants with abnormality in routine urinalysis parameters
Urine samples will be collected to evaluate specific gravity, leucocyte esterase, nitrite, blood, bilirubin, protein, glucose, ketones and urobilinogen.
Time frame: up to 90 days after the last administration
Number of participants with abnormality in ECG parameters
12-lead ECG will be obtained using an ECG machine. Participants will be in supine or a semi-recumbent position (about 30 degrees of elevation) and rested for approximately 2 minutes before ECGs are recorded.
Time frame: up to 90 days after the last administration
EFS （Event Free Survival）
defined as time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, or death due to any cause
Time frame: up to 3 years
major pathological response (MPR) rate
defined as ≤ 10% residual viable tumor cells in the surgically resected primary tumor and lymph nodes
Time frame: Approximately 21 to 28 days after operation
radical resection (R0 resection) rate
defined as free resection margins, systematic node dissection or sampling, and the highest mediastinal node negative for tumor
Time frame: Approximately 21 to 28 days after operation
ORR （Objective Response rate,）
defined as the ratio of subjects who have achieved investigator assessed complete response (CR) and partial response (PR) per RECIST v1.1
Time frame: Within 7 days before surgery
OS （Overall Survival）
defined as the time from randomization to death from any cause
Time frame: up to 3 years
Immunogenicity
includes the positive rate of anti-drug antibody (ADA) and neutralizing antibody (NAb) in subjects
Time frame: From date of randomization to 30 days after last dose of the drug
maximum concentrations (Cmax )
Maximum serum concentration that IBI110 and Sintilimab achieves in the body after the drug has been administered and before the administration of a second dose.
Time frame: from first administration of IBI110 to 3 days before the operation
the area under the drug plasma concentration-time curve (AUC)
Area under the concentration-time curve from time zero to last measurable concentration (AUC)
Time frame: from first administration of IBI110 to 3 days before the operation
half-life (t1/2)
defined as the time it takes for the concentration of IBI110 and Sintilimab in the plasma or the total amount in the body to be reduced by 50%.
Time frame: from first administration of IBI110 to 3 days before the operation
clearance (CL)
a pharmacokinetic measurement of the volume of plasma from which IBI110 and Sintilimab are completely removed per unit time
Time frame: from first administration of IBI110 to 3 days before the operation
volume of distribution (V).
calculated by the amount of the drug in the body divided by the plasma concentration.
Time frame: from first administration of IBI110 to 3 days before the operation