A Phase 3 interventional study of Sintilimab and Carboplatin in Squamous Cell Non-small Cell Lung Cancer, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-12-14.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment
This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.
This is a Phase 3, prospective, randomized, open-label, multi-center study that assesses the efficacy and safety of neoadjuvant therapy with different cycles of sintilimab combined with chemotherapy for Resectable Squamous Cell NSCLC. In this trial, eligible subjects will be randomly assigned to arm A and arm B (1:1). Subjects in arm A will receive 3 cycles of neoadjuvant sintilimab with chemotherapy and arm B will receive 4 cycles of neoadjuvant sintilimab with chemotherapy, followed by surgery within the 3-5th week after the last dose of sintilimab. After operation, both subjects in arm A and B can receive the treatment of sintilimab for up to 1 year according to the requirements of patients. The primary purpose is MPR rate of Resectable Squamous Cell NSCLC with different cycles of sintilimab combined with chemotherapy, which is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 250 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate organ function and it should meet the following criteria:
Absolute value of neutrophils (ANC) ≥1.5×109/L in the absence of granulocyte colony stimulating factor for the past 14 days; Platelet ≥100×109/L in the last 14 days without blood transfusion; Hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin in the last 14 days ;
Total bilirubin(TBIL)≤1.5ULN, ALT、AST≤ 2.5 ULN, serum creatinine(sCr)≤1.5ULN;
Good blood coagulation: INR≤1.5 or PT≤1.5 ULN;
Normal thyroid function: TSH within normal institutional limits;
Exclusion Criteria:
Systemic glucocorticoid therapy (excluding local glucocorticoids by nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy is in progress within 7 days before the first dose.
Note: it is allowed to use physiological dose of glucocorticoid (Prednisone≤10 mg/d or equivalent drug).
Inoculate the live vaccine within 30 days before the first dose (cycle 1 day 1).
Note: it is allowed to receive the injection inactivated virus vaccine for seasonal influenza within 30 days before the first dose; however, it is not allowed to accept the live attenuated influenza vaccine for intranasal medication.
There are any serious or uncontrollable systemic diseases, such as:
Resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are serious and difficult to control,such as complete left bundle branch block, heart block above degree Ⅱ, ventricular arrhythmia or atrial fibrillation;
Unstable angina, congestive heart failure, chronic heart failure with NYHA grade ≥ 2;
Within 6 months before inclusion, there were any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack etc;
History of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose,or having currently clinical active interstitial lung diseases;
Active pulmonary tuberculosis;
Active or uncontrolled infections requiring systemic treatment;
Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
Poorly controlled diabetes (Fasting blood glucose (FBG)>10mmol/L);
Urine routine test indicates that urine protein≥++, and confirmed that 24 hours proteinuria>1.0 g;
Patients with mental disorders who are unable to cooperate with the treatment;
Neoadjuvant: Prior to surgery, participants receive up to 3 cycles (cycle length: 3 weeks) of sintilimab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with neoadjuvant chemotherapy, consisting of albumin-bound paclitaxel \[260 mg/m\^2, IV; given on cycle day 1\] and carboplatin \[AUC 5- 6mg/mL/min, IV; given on cycle day 1 \] . Adjuvant: Followed by surgery within the 3-5th week after the last dose of sintilimab, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient. The maintenance treatment of sintilimab \[200 mg, intravenous (IV); given on cycle day 1; cycle length: 3 weeks\] may be selected upon subject request for up to 1 year.
Biological: Sintilimab · Drug: Carboplatin · Drug: Albumin-Bound Paclitaxel
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of sintilimab \[200 mg, intravenous (IV); given on cycle day 1\] in combination with neoadjuvant chemotherapy, consisting of albumin-bound paclitaxel \[260 mg/m\^2, IV; given on cycle day 1\] and carboplatin \[AUC 5- 6mg/mL/min, IV; given on cycle day 1 \] . Adjuvant: Followed by surgery within the 3-5th week after the last dose of sintilimab, the researcher will decide whether to radiotherapy or not according to the clinical situation and pathological stage of the patient. The maintenance treatment of sintilimab \[200 mg, intravenous (IV); given on cycle day 1; cycle length: 3 weeks\] may be selected upon subject request for up to 1 year.
Biological: Sintilimab · Drug: Carboplatin · Drug: Albumin-Bound Paclitaxel
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Also known as: IBI308, PD-1 antibody
AUC 5-6 mg/mL/min by IV infusion Q3W, given on cycle day 1.
260 mg/m\^2 by IV infusion Q3W, given on cycle day 1.
Major pathological response rate (MPR)
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the pathological examination of resected specimens.
Time frame: At time of surgery
Pathology complete response rate(pCR)
pCR rate is defined as the percentage of participants lacking of evidence of viable tumor cells in the pathological examination of resected specimens.
Time frame: At time of surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants having a complete response or a partial response, measured by RECIST 1.1.
Time frame: prior to surgery
2 years disease-free survival rate (DFS)
2 years DFS rate is defined as the percentage of participants having no recurrence, distant metastasis or death within 2 years after operation.
Time frame: 2 years postoperatively
2 years overall survival rate (OS)
2 years OS rate is defined as the percentage of participants having no death of any cause within 2 years after operation.The Kaplan-Meier estimator will be used to estimate median OS and its 95%CI and the survival curve.
Time frame: 2 years postoperatively
2 years event free survival (EFS)
2 years EFS rate is defined as the percentage of participants having no radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause within 2 years after randomization.
Time frame: 2 years after randomization
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
Second Affiliated Hospital, School of Medicine, Zhejiang University