Non-small cell lung cancer
Conditions
Interventions
Experimental Group:tislelizumab in combination with chemotherapeutic conversion therapy
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and PeKing Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); 2) Willingness to follow and ability to complete all trial procedures; age =18 years and =75 years at the time of signing the ICF; 3) Pathologically confirmed diagnosis of stage III-N3 NSCLC (according to AJCC 8th edition TNM staging); primary lesion: histologic or cytologic diagnosis obtained by lung puncture, bronchoscopy, or sputum examination; N3 lymph node diagnosis obtained by biopsy through EBUS/EUS/thoracoscopic/mediastinoscopic pathologic testing or fine-needle aspiration, or, if it is difficult to obtain a pathological diagnosis of the primary lesion, lymph node pathology may be an alternative. 4) Technically resectable as assessed by the surgeon: no extensive fusion of lymph nodes and no lymph node invasion of surrounding organs such as the trachea, bronchi, heart, large blood vessels, etc. that would make resection impossible. 5) Not have received any treatment including radiotherapy, surgery, chemotherapy, or immune checkpoint inhibitors within 5 years. 6) Be a first-time patient or fully eligible for enrollment who has already been treated with the study drug. 7) ECOG PS score of 0 or 1 within 7 days before the first dose of the study drug; 8) Expected survival = 12 weeks (3 months); 9) The main organs are functioning well.
Exclusion criteria
Exclusion criteria: 1) Patients with stage III-N3 NSCLC with EGFR-sensitive mutations and ALK rearrangements by histologic or genetic testing. 2) Other active malignancies within 5 years or concurrently. Cured limited tumors such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast are eligible for enrollment. 3) Patients who are preparing for or have previously undergone organ or bone marrow transplantation. 4) Any unstable systemic disease including, but not limited to, active infection, unstable angina pectoris, cerebrovascular accident or transient ischemia (within 6 months before Screening), myocardial infarction (within 6 months before Screening), congestive heart failure (New York Heart Association (NYHA) Classification = Class II), severe cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease. 5) Poorly controlled hypertension (defined as systolic blood pressure (BP) =160 mmHg and/or diastolic BP =100 mmHg), previous hypertensive crisis, or hypertensive encephalopathy. 6) History of peptic ulcer, gastrointestinal perforation, erosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, or intra-abdominal abscess within 6 months before Screening. 7) Test positive for hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, or syphilis. 8) Have active tuberculosis. 9) Patients with pre-existing and current interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity. 10) Patients with known active or suspected autoimmune disease. Enrollment of patients who are in a stable state and do not require systemic immunosuppressive therapy is permitted. 11) Subjects who are hepatitis B surface antigen (HBsAg) positive and have a peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer test = 1 x 10 3 copies/L. If HBsAg is positive and peripheral blood HBV DNA titer test is 10 mg/day prednisone efficacy dose) or other immunosuppressive medications within 14 days before the first dose or during the study period. However, enrollment is permitted if patients are permitted to be treated with topical or inhaled glucocorticosteroids and adrenal glucocorticoid replacement therapy at doses = 10 mg/day prednisone efficacy dose in the absence of active autoimmune disease. 14) Development of any active infection requiring systemic anti-infective therapy within 14 days before first dose. 15) Participation in another clinical study or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study. 16) Have a known history of severe allergy to any monoclonal antibody and chemotherapeutic drug components. 17) Women who are pregna
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response rate, MPR; R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathological complete remission rate;time to distant metastasis (TTDM);event-free survival (EFS);overall survival, OS;rate of surgical complications/CD-grade III or higher (based on the Clavien-Dindo classification of post-surgical complications) ;Surgery-related outcomes (surgical approach, extent of resection, duration of surgery, etc.);erthe centage of surgery;objective response rate, ORR;event free survival, EFS;overall survival, OS; | — |
Countries
China
Contacts
Public ContactKai Ma
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and PeKing Union Medical College
Outcome results
None listed