Non-small cell lung cancer
Conditions
Interventions
Experimental group:Parbolizumab 200mg + paclitaxel 200mg/m2 (or other agents indicated by genetic testing) + carboplatin AUC 6 IV Q3W × 4 cycle
Control group:Direct operation: after operation, pabolizumab 200mg+paclitaxel 200mg/m2 (or other drugs indicated by gene testing)+carboplatin AUC 6 IV Q3W × 4 cycles, continue to maintain 200 mg of pa
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 at registration. 2. Prior to patient registration and any protocol-related procedures, sign a written informed consent in accordance with ICH-GCP regulations. 3. Pathologically proven NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or non-otherwise designated NSCLC). 4. The tumor was staged II-IIIA according to TNM (8th edition). 5. According to the decision of the Multidisciplinary Oncology Committee prior to neoadjuvant therapy, the tumor is considered resectable. Resectable means that complete excision can be achieved according to Rami-Porta. 6. Disease that can be measured by PET/CT and contrast-enhanced CT scans according to RECIST 1.1 criteria (longest diameter of non-lymph node lesions =10 mm, short axis of lymph nodes =15 mm). 7.ECOG score 0-1. 8. Appropriate Lung Function Based on the ESTS Guidelines: For pneumonectomy: FEV1 and DLCO =80%. If one of the two. 80%, the peak VO2> of exercise test is required; 75% or 20ml/kg/min. Resection is smaller than pneumonectomy: exercise test peak VO2=35% or =10ml/kg/min, FEV1 and DLCO are expected to be =30% after surgery. 9. Hemoglobin = 90 g/L, absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L. 10. Good liver function: bilirubin = 1.5 x ULN, AST/ALT = 1.5 x ULN, AP = 2.5 x ULN. 11. Good renal function: creatinine clearance =60 mL/min was calculated according to Cockcroft-Gault formula. 12. The patient is willing and able to comply with the protocol during the study, including treatment and scheduled visits and examinations, including follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of any distant metastasis or N3 disease. Brain metastases must be ruled out by CT or MRI. 2. Carry EGFR-TKI mutation or ALK mutation. 3. Past or associated with malignant tumors within 5 years prior to registration. 4. Any previous treatment for non-small cell lung cancer. 5. Any previous treatment with PD-1 or PD-L1 inhibitors. 6. Previous chest radiation therapy. 7. Use of corticosteroids as absolute contraindications for preoperative medication. 8. Treatment with other experimental drugs or other anti-cancer therapies, within 30 days prior to registration in clinical trials. 9. Severe or uncontrolled heart disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris (even if controlled by medication), history of myocardial infarction within the past 3 months, severe arrhythmias requiring medication (other than atrial fibrillation or paroxysmal supraventricular tachycardia). 10. Preexisting peripheral neuropathy (> Level 1). 11. Weigh less than 30 kg. 12. A documented history of an active autoimmune disease requiring systemic treatment within the past 3 months, or a clinically severe autoimmune disease or syndrome requiring systemic use of steroids or immunosuppressants. 13. Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis). 14. Known evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. 15. History of primary immunodeficiency. 16. History of allotransplantation. 17. A known history of clinically diagnosed tuberculosis. 18. Patients with a history of interstitial lung disease cannot be enrolled if they have symptomatic ILD (level 3-4). 19. Known allergy to the test drug or any excipients. 20. Pregnant or lactating women. Any other serious underlying medical conditions (such as uncontrolled diabetes, active uncontrolled infections, active gastric ulcers, uncontrolled seizures, severe hearing impairment), mental, psychological, family, or geographic conditions that, in the investigator's judgment, may interfere with planned staging, treatment, and follow-up, Affect patient compliance or put patients at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;OR; | — |
Countries
China
Contacts
Public ContactLiu Hongsheng
Peking Union Medical College Hospital
Outcome results
None listed