Lung Cancer
Conditions
Interventions
experimental group:triplezumab combined with platinum-based dural neoadjuvant chemotherapy
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily join the study, sign the informed consent form, have good compliance and cooperate with the follow-up. 2. Male or female patients aged from 18 to 75 years old (including the margin age); 3. Patients with histological or cytological confirmed less than stage IIIA non-small cell lung cancer (according to AJCC TNM stage, version 8); 4. Did not previously receive any systemic treatment for current NSCLC diseases including chemotherapy, targeted therapy, radiation therapy or immunotherapy; 5. Patients have at least one target lesion with a measurable diameter according to the RECIST 1.1 standard (CT scan with a long diameter of >= 10 mm for the tumors, or CT scan with a short diameter of >= 15 mm for lymph nodes, and the lesions have not received radiotherapy, cryosurgery and other local treatment; 6. Patients with the ability to comply with the protocol, including the surgery; 7. ECOG physical status score 0~2 points (see Annex 2); 8. The baseline blood routine and biochemical indexes of the subjects meet the following criteria: (1) Hemoglobin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; (2) Serum total bilirubin = 30g/L; 9. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative and are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial medication. For men, it should be surgical sterilization, or agree to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the trial medication.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria cannot be enrolled: 1. Exclusion criteria for target diseases: 1) Patients with histological or cytological confirmed small cell lung cancer (SCLC) or mixed with SCLC; 2) Previously received systemic therapy for the targeted disease; 3) Patients without measurable lesions; 4) Previously received treatment of PD-1/PD-L1 or cytotoxic T lymphocyte associated protein 4 (CTLA-4) antibodies. 2. Exclusion criteria for medical history and complications 1) Patients with active, known or suspected autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Patients with autoimmune-associated hypothyroidism who receive hormone replacement therapy with stable dose thyroid are eligible to this study. Patients with vitiligo or asthma have been completely relieved in childhood and do not have any intervention in adults can be included in this study. Asthma patients who require intermittent bronchodilators, inhaled steroids or topical steroid injections will not be excluded from the study. 2) Patients who need to receive systemic corticosteroids (dose equivalent to prednisone > 10 mg / day) or other immunosuppressive medications within 14 days before the first administration of study treatment; In the absence of active autoimmune disease, patients with inhaled or topical corticosteroids are allowed to be enrolled, as well as adrenocorticoid replacement therapy with an effective dose of prednisone = grade II myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; grade III ~ IV heart fa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathologic response raet;Surgical resection rate;R0 resection rate;Relapse free survival;Overall survival;Time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactFen Wang
Oncology Department, Shenzhen Hospital, Peking University
Outcome results
None listed