Non-small cell lung cancer
Conditions
Interventions
EGFR sensitive mutations (including exon 19 deletion, L858R or T790M, both alone or coexist with other EGFR mutations):Osimertinib, 80 mg, orally, once a day, 21 days as a cycle, 2-4 cycles
surgery is performed 2-4 cycles after the first use of the drug. CT evaluation, pathological biopsy, etc. before the first medication and before surgery
ALK fusion mutation:Crizotinib, 250mg, orally, once a day, 21 days as a cycle, 2-4 cycles
surgery 2-4 cycles after the first use of the drug. CT evaluation, pathological biopsy, etc. before the first medication and before surgery
ROS1 fusion mutation:Crizotinib, 250mg, orally, once a day, 21 days as a cycle, 2-4 cycles
surgery 2-4 cycles after the first use of the drug. CT evaluation and pathological biopsy before the first medication and surgery
MET-sensitive mutations (including exon 14 deletion, amplification, alone or coexist with other MET mutations):Crizotinib, 250mg, orally, once a day, 21 days as a cycle, 2-4 cycles
Without any of the above sensitive mutations:Duvalizumab (10mg/kg) + platinum-based dual-drug chemotherapy, intravenous infusion (over 60 minutes), once each 6 and 3 weeks before surgery (42nd and 21s
surgery is performed 2-4 cycles after the first medication. CT evaluation and pathological biopsy before&
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form; 2. Ability to follow the research protocol and follow-up procedures; 3. Patient age >= 18 years; 4. Preoperative histology or cytology confirmed NSCLC (puncture biopsy), enhanced chest CT, liver and adrenal gland CT, head magnetic resonance, PET-CT/whole body bone imaging, etc., which are clearly initial patients of stage IIIA-N2 (according to NCCN2019 Edition staging standard); 5. The patient must have measurable lesions (according to the RECIST1.0 standard); 6. Have sufficient lung function to withstand surgery; 7. The ECOG score of physical strength is 0/1; 8. Life expectancy is at least 12 weeks; 9. The following laboratory tests performed within 7 days before the first medication confirmed that the patients bone marrow, liver and kidney functions were in line with the participation Research requirements: -Hemoglobin >= 9.0g/dL (this level can be maintained or exceeded by blood transfusion); Red blood cell count >= 2.0 x 10^9/L – Absolute neutrophil count (ANC) >= 1.0 x 10^9/L; -Platelet count >= 100 x 10^9/L; -Total bilirubin is within the normal limit; -Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 60ml/min; – The international normalized ratio of prothrombin time (INR) <= 1.5, and partial thromboplastin time (APTT) <= 1.5 times the upper limit of normal for patients who have not received anticoagulant therapy. Patients receiving full-dose or parenteral anticoagulant treatment can enter clinical trials as long as the dose of anticoagulant drugs is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test test are within the limits of local treatment. -Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result is negative. -Male and female patients of appropriate age must use reliable methods of contraception before entering the trial and during the study until 30 days after stopping the drug. The reliable method of contraception will be determined by the principal investigator or designated personnel.
Exclusion criteria
Exclusion criteria: 1. Active, known or suspected autoimmune disease. (Patients with vitiligo, type 1 diabetes, autoimmune thyroiditis requiring hormone replacement therapy, and other autoimmune diseases without recurrence can be included); 2. Any systemic anti-cancer therapy for NSCLC, including cytotoxic drug therapy, targeted therapy, immunotherapy, and experimental therapy; 3. Operated for NSCLC; 4. Local radiotherapy for NSCLC; 5. Patients who had cancers other than NSCLC within five years before the start of treatment in this study. Exclude non-melanoma skin cancer, bladder cancer in situ/gastric cancer/colon cancer/breast cancer/cervical cancer; 6. Any unstable systemic disease (including active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (= New York Heart Association [NYHA] II Grade), heart machine infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney or metabolic diseases; 7. Past or present suffering from interstitial lung disease; 8. Systemic infection requiring treatment, positive for HBV surface antigen or positive for HCV ribonucleic acid; 9. Past or current detection of human immunodeficiency virus (HIV) or AIDS; 10. Allergic to study drugs; 11. Patients who have undergone major surgery or suffered severe trauma within 2 months before the first medication; 12. Any malabsorption; 13. Other researchers think it is not suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological remission rate;Objective response rate;R0 removal rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;5-year survival rate;Surgical complications rate; | — |
Countries
China
Contacts
Public ContactZhu Yuming
Outcome results
None listed