Non-Small Cell Lung Cancer
Conditions
Interventions
Test group:Tislelizumab,200mg,Q3W + Carboplatin(AUC:5mg/mL/min)or Cisplatin(75 mg/m2),Q3W + Pemetrexed or Gemcitabine or Paclitaxel or Paclitaxel(Albumin Bound)
Sponsors
Tianjin Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage ?-?B(N2) with resectable NSCLC confirmed by imaging or pathological examination (according to Stage 8) 2. The tumor can be resected after evaluation by the competent physician. 3. No previous treatment. 4. ECOG PS score: 0-1; 5. Ability to provide an informed consent form (ICF) and to understand and agree to adhere to study requirements and evaluation schedules. 6. Male or female over 18 years old at the time of signing the ICF. 7. Measurable lesions were assessed by the investigators according to RECIST version 1.1 8. Lung and heart function are satisfactory and confirmed to meet the requirements for surgical excision for the purpose of radical treatment. 9. Adequate organ function, including the following: ? Bone marrow: Absolute neutrophil count (ANC) = 1.5 x 109/L, platelet = 100 x 109/L, hemoglobin = 9 g/dL. ? Liver: total bilirubin = 1.5 times upper normal limit (ULN), liver transaminase: aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) = 2.5 times ULN. ? Kidney: Creatinine clearance = 45 mL/min using the standard Cockcroft-Gault formula. 10. For women: surgical sterilization, post-menopause or effective pregnancy avoidance methods are required during or for three months after treatment; No pregnancy or lactation; Women who are fertile need a negative pregnancy test.
Exclusion criteria
Exclusion criteria: 1. The patient had been treated with anti-PD-1, PD-L1, or CTLA-4 immune checkpoint inhibitors. 2. Known to carry epidermal growth factor receptor (EGFR) mutations or ALK gene translocations; For patients with non-squamous cell carcinoma, tumor tissue-based EGFR results must be provided; In patients with squamous non-small cell lung cancer, EGFR mutation status is not required for screening; Patients with unknown ALK fusion gene status (both non-squamous cell carcinoma and squamous cell carcinoma) are not required to be tested 3. Patients who are not expected to tolerate surgery, such as cardiopulmonary insufficiency. 4. Present or present with other malignancies in the past 2 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]. 5. Allergy to any study drug or excipients. 6. Patients with active viral hepatitis who have been determined by the investigators to require treatment: chronic hepatitis B virus carriers with A. HBV DNA=500IU/mL (2500 copies /mL) (HBV DNA testing was only performed for patients who tested positive for hepatitis B core antibody ); B.cv RNA test positive patients (HCV RNA test was performed only in patients with hepatitis C virus antibody positive). 7. Patients with active autoimmune diseases requiring systemic treatment who were assessed by the investigator as having an impact on study therapy. 8. Patients with long-term heavy use of hormones or other immunomodulators that the investigators assessed as having an impact on study therapy. 9. Study surgical incisions that have not healed before treatment began (small biopsy incisions may be included). 10. There are active infected persons. 11. Live or attenuated vaccine was administered in the 30 days prior to the first administration of tirelizumab or was planned to be administered during the study period. 12. Suffering from severe cardiovascular diseases: Grade ? or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; According to NYHA standard, patients with grade ? to ? cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by color Doppler examination. 13. History of interstitial lung disease, uncontrolled systemic disease, including diabetes mellitus, hypertension, acute lung disease, etc. 14. Human immunodeficiency virus (HIV) infection is known. 15. Any major surgery requiring general anesthesia has been performed within 28 days or less prior to initial administration. 16. There is an underlying medical condition or alcohol/drug abuse or dependence that is not conducive to study drug administration, or may affect the interpretation of results, or place patients at high risk of developing treatment complications. 17. Simultaneously participate in another therapeutic clinical study. 18. Pregnant or lactating women, men and women who planned to have children during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response rate;objective response rate;Event Free Survival, EFS;Overall survival; | — |
Countries
China
Contacts
Public ContactSun Daqiang
Tianjin Chest Hospital
Outcome results
None listed