NSCLC
Conditions
Interventions
Experimental Group:Neoadjuvant therapy of Tislelizumab with chemotherapy
Sponsors
Beijing Tsinghua Chang Gung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Written informed consent provided. 2.18-70 years old, all gender; 3. Histologically confirmed stage III unresectable NSCLC without prior treatment (AJCC Stage 8) : These included N2 with single-station ipsilateral mediastinal lymph node metastasis with a short diameter of =3cm, N2 with multi-station and multi-station fusion mass (lymph node with a short diameter of =2cm on CT), N3 with single-station supravicular or contralateral mediastinal lymph node metastasis, and T3 and T4 with tumors > 5cm and/or invasion of the chest wall, diaphragm, pericardium, great vessels, and carina. cTNM staging was confirmed by PET/CT or pathological biopsy. 4. According to the solid tumor efficacy evaluation standard version 1.1; 5.ECOG(eastern cooperative oncology group) performance status score 0-1; 6. Adequate organ function: (1) Hematology: absolute neutrophil count =1500/uL; Platelet =100000/uL; Hemoglobin =9.0g/dL or =5.6mmol/L; (2) Kidney: serum creatinine =1.5 ULN or calculated creatinine clearance (CrCl) =45mL/min; (3) Liver: direct bilirubin within normal limits for subjects with total bilirubin =1.5×ULN or with total bilirubin >1.5×ULN; AST (SGOT) and ALT (SGPT) =2.5×ULN; (4) Endocrine system: thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, then subjects can still meet the inclusion criteria; (5) Coagulation function: International Standardized Ratio (INR) or thrombin time (PT) or activated partial thrombin time (APTT) =1.5×ULN, except for subjects receiving anticoagulant therapy, as long as PT or APTT is within the proposed use range of anticoagulant drugs; 7. Willing and able to comply with study plan visits, treatment plans, laboratory tests and other research procedures; 8. Adequate cardiopulmonary function was able to tolerate the proposed pneumonectomy;
Exclusion criteria
Exclusion criteria: 1.Previously received systemic anti-tumor therapy for non-small cell lung cancer. 2.history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment. 3.History or active pulmonary tuberculosis. 4.Active infections that require systemic treatment. 5.History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy. 6.Untreated active Hepatitis B. 7.Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). 8.Grade 3 or above peripheral neuropathy. 9.Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs. 10.Underlying severe or uncontrolled disease. 11.Malignant tumors other than NSCLC within 5 years. 12.Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of >10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resectability rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR);Pathology complete response rate(pCR);R0 Resection rate;Perioperative G3-4 Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactDr. Donghong Chen
Beijing Tsinghua Chang Gung Hospital
Outcome results
None listed