camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable nsclc

Conditions: Non-small-cell Lung Cancer (NSCLC)

Summary: explorative study, which evaluates the effect of camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.

this is a multicenter, randomized, open parallel controlled trial to evaluate the efficacy and safety of camrelizumab combined with albumin-bound paclitaxel and platinum versus albumin-bound paclitaxel combined with platinum in resectable stage iiia -iiib nsclc (iiib is limited tot3n2).

Eligibility criteria:
inclusion criteria: * age :18 years to 70 years (adult, older adult) * ecog physical score status of 0 or 1 points; * expected survival time ≥ 12 weeks; * pathological diagnosis with stageiiia-iiib nsclc; * according to the eighth edition of the ajcc/uicc tnm staging system, patients was pathological diagnosed with stage iii-n2 clinically resectable nsclc. * patients with at least one evaluable or measurable lesions as per recist version 1.1 （ct scan length and diameter of tumor lesion≥10mm，ct scan of lymph node lesion was short diameter≥15mm；） * patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment. * patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer. * the main organ function meets the following criteria:1) blood routine:a. anc ≥ 1.5×109/l; b. plt ≥ 100×109/l; c. hb ≥ 90 g/l; 2) blood biochemistry:tbil ≤ 1.5×uln;alt、ast≤ 2.5×uln;scr≤1.5×uln; 3) blood coagulation: inr≤1.5×uln and aptt≤1.5×uln，endogenous creatinine clearance rate≥50ml/min(cockcroft-gault formula); * pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. they shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. for men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug; * patient has to voluntarily join the study and sign the informed consent form for the study. exclusion criteria:the subject must be excluded from participating in the trial if the subject: * patients with brain metastasis * patients with autoimmune disease, or a history of autoimmune disease including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included. * subjects who need medical intervention with bronchodilators cannot be included. * subjects with congenital or acquired immunodeficiency such as hiv infection, active hepatitis b (hbv dna ≥ 2000 iu/ml), hepatitis c (hepatitis c antibody is positive); * subjects with a condition requiring other immunosuppressive medications before 14 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents). * has received a live vaccine within 4 weeks of planned start of study therapy. * other malignancies have been diagnosed within 3 years prior to the first use of the study drug; 8. patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function. * patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmhg and diastolic blood pressure ≥90 mmhg); * patients with myocardial ischemia and myocardial infarction above class ii (including qt interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms); * severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (\> 38.5 ℃) within 4 weeks before the first administration. * allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. * pregnant or nursing women; 14. patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients. * participated in other clinical trials within 4 weeks; 16. patients with the history of drug abused or alcohol. * the investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;

Keywords: camrelizumab neoadjuvant treatment