Non-Small Cell Lung Cancer
Conditions
Interventions
Test group:Tislelizumab (200mg, Q3W) combined with chemotherapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with stage II-IIIB (N2) NSCLC confirmed by histopathology or cytopathology (according to 8th edition staging) 2. Tumor resectable or potentially resectable as assessed by a competent surgeon. 3. previously untreated. 4. ECOG PS score: 0-1. 5. Able to provide informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule. 6. Male or female aged 18 years or older at the time of signing the ICF. 7. assessed by the investigator as a measurable lesion according to RECIST version 1.1 8. good pulmonary and cardiac function, confirmed to be eligible for surgical resection for the purpose of radical treatment 9. adequate organ function, including the following. - Bone marrow: absolute neutrophil count (ANC) = 1.5 x 109/L, platelets = 100 x 109/L, hemoglobin = 9 g/dL - Liver: total bilirubin = 1.5 times upper limit of normal (ULN), liver transaminases: aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) = 2.5 times ULN. - Renal: creatinine clearance = 45 mL/min (using the standard Cockcroft-Gault formula). 10.For females: must be surgically sterilized, post-menopausal, or use highly effective methods of contraception during or within 3 months of treatment; no pregnancy, no breastfeeding; women of childbearing potential need a negative pregnancy test.
Exclusion criteria
Exclusion criteria: 1. the patient has been treated with an immune checkpoint inhibitor such as anti-PD-1, PD-L1 or CTLA-4 2. known to harbor epidermal growth factor receptor (EGFR) mutations, ALK and ROS1 gene translocations; for patients with non-squamous cell carcinoma, tumor tissue-based EGFR, ALK and ROS1 assays must be provided; for patients with squamous non-small cell lung cancer, testing at screening is not required if EGFR mutation status, ALK mutation status and ROS1 mutation status are unknown 3. patients who are not expected to tolerate surgery such as cardiopulmonary insufficiency 4. Patients who have had or currently have other malignancies within the past 5 years, with the exception of 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 basement membrane)]. 5. allergy to any study drug or excipient 6. Patients with active viral hepatitis requiring treatment as determined by the investigator: a. Chronic hepatitis B virus carriers with HBV DNA = 500 IU/mL (2500 copies/mL) (HBV DNA testing only for patients who test positive for hepatitis B core antibody ); b. Patients who test positive for HCV RNA (only for patients who test positive for hepatitis C virus antibodies. 7. patients with active autoimmune disease requiring systemic therapy that the investigator assesses as having an impact on study treatment 8. Patients on long-term heavy hormone use or use of other immunomodulators that the investigator assesses to have an impact on study treatment. 9. Surgical incisions that have not healed prior to the start of study treatment (small biopsy incisions may be enrolled). 10. Patients with active infection. 11. have received a live or attenuated vaccine within 30 days prior to the first dose of tirelizumab or are scheduled to receive a live or attenuated vaccine during the study. 12. Have severe cardiovascular disease: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; Grade III-IV cardiac insufficiency by NYHA criteria, or cardiac ultrasound suggestive of left ventricular ejection fraction (LVEF) <50%. 13. history of interstitial lung disease, uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc. 14. Known human immunodeficiency virus (HIV) infection. 15. Have had any major surgery requiring general anesthesia within = 28 days prior to the first dose. 16. Presence of an underlying medical condition or alcohol/drug abuse or dependence that is detrimental to the administration of the study drug, or that may affect interpretation of the results, or that places the patient at high risk of developing treatment complications. 17. Concurrent participation in another therapeutic clinical study. 18. Pregnant or lactating women, or male and female patients who plan to have children during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response;R0 resection rate;Objective response rate;Event Free Survival;Overall survival; | — |
Countries
China
Contacts
Public ContactMinglei Zhuo
Beijing Cancer Hospital
Outcome results
None listed