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.
Sign the informed consent form before starting any trial related procedure.Be willingness and able to undergo planned visits, protocol therapy, laboratory tests and other testing procedures.
18-75 years old, male or female.
Squamous Cell Non-small cell lung cancer confirmed by cytology or histology.
There must be at least one evaluable focus judged according to recist1.1 standard.
Malignancies within 5 years prior to the first dose(excluding radical skin basal cell carcinoma, skin squamous cell carcinoma and / or radical resection of carcinoma in situ).
Currently participating in the intervention clinical treatment, or receiving other drugs or research instruments within 4 weeks before the first dose.
Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or drugs for another stimulation or synergistic inhibition of T cell receptor (e.g. CTLA-4, OX-40, CD137).
Active autoimmune diseases requiring systemic treatment (e.g. using disease improving drugs, corticosteroids or immunosuppressants) occurred within 2 years before the first dose. Alternative therapies (e.g. thyroxine, insulin or corticosteroids in physiological doses for adrenal or pituitary insufficiency) are not considered systemic treatment.
Parallel
Sintilimab
Biological/Vaccine200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
Carboplatin
DrugAUC 5-6 mg/mL/min by IV infusion Q3W, given on cycle day 1.
Albumin-Bound Paclitaxel
Drug260 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.
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.
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.
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.
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.
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