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Development strategy adjustment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI110+sintilimab | Experimental | IBI110 and sintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. IBI110 and sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year. |
|
| sintilimab | Active Comparator | Sintilimab will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase. Sintilimab will be administered as IV infusion 3 weeks during the post-operative adjuvant phase up to 1 year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI110 | Drug | R2PD d1 IV every 3 weeks |
| |
| sintilimab |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | defined as having no residual visible tumor cells in the surgically resected primary tumor and lymph node samples (ypT0N0) | 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. | 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. | 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 3 years |
| major pathological response (MPR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300000 | China |
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| Drug |
200mg d1 IV every 3 weeks |
|
| 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. | 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. | 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. | up to 90 days after the last administration |
defined as ≤ 10% residual viable tumor cells in the surgically resected primary tumor and lymph nodes
| 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 | 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 | Within 7 days before surgery |
| OS （Overall Survival） | defined as the time from randomization to death from any cause | up to 3 years |
| Immunogenicity | includes the positive rate of anti-drug antibody (ADA) and neutralizing antibody (NAb) in subjects | 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. | 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) | 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%. | 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 | 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. | from first administration of IBI110 to 3 days before the operation |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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