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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGMajor 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
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