non-small cell lung cancer
Conditions
Interventions
camrelizumab+apatinib:Camrelizumab 200mg IV, q3w, 2 cycles, on Day -28 and Day- 14 (+/- one day) prior to planned surgery
Apatinib 250 mg, p.o., qd, 6 weeks
followed by enhanced CT or PET-CT
followed by radical surgery.
camrelizumab plus apatinib and chemotherapy:Camrelizumab 200mg and platinum-doublet chemotherapy IV, q3w, 2 cycles, on Day -28 and Day- 14 (+/- one day) prior to planned surgery
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1; 3. Histological or cytological diagnosis of NSCLC by needle biopsy, and clinical stage IB-IIIA(N2 single lymph node station) according to the TNM classification (8th edition) validated by radiological examination or EBUS; 4. Without specific driven gene mutation like EGFR, ALK and so on; 5. At least 1 measurable lesion according to RECIST 1.1; 6. Life expectancy is at least 12 weeks; 7. Adequate hematological function, liver function and renal function: Hemoglobin greater than or equal to 9.0 g/dL (which can be maintained or exceeded by blood transfusion); Red blood cell count greater than or equal to 2.0 x 10^9/L; Absolute neutrophil count (ANC) greater than or equal to 1.0x10^9/L; Platelet count greater than or equal to 100 x 10^9/L; Total bilirubin within the normal limit; Upper limit of normal value of alanine glutamate transaminase, straw glutamate transaminase and alkaline phosphatase less than 2.5 times; Creatinine less than or equal to 2.0 mg/dL;Creatinine clearance rate greater than or equal to 60ml/min; The international standardized ratio of prothrombin time (INR) is less than or equal to 1.5 in patients who have not received anticoagulation therapy, and the upper limit of partial thrombin time (APTT) is less than or equal to 1.5 times the normal value.Patients receiving full or extra-gastrointestinal anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant 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; 8. Without systemic metastasis; 9. With the feasibility of radical surgery therapy; 10. Patients with normal lung function can tolerate surgery; 11. Women of child-bearing age must undergo a pregnancy test within 7 days before starting treatment and the results are negative; 12. Signed and dated informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous systemic anti-tumor treatment of NSCLC, including surgery, chemotherapy, local radiotherapy, targeted therapy or other exploratory therapy; 2. Having the history of other tumors except NSCLC within 5 years ago; 3. Any unstable systemic comorbidity (e.g. uncontrolled hypertension, severe arrhythmia, etc.); 4. Any active, diagnosed or suspected autoimmune diseases; 5. Be allergic to any component of camrelizumab; 6. Previous or current interstitial lung disease; 7. Human immunodeficiency virus (HIV) infection; 8. Patients undergoing major surgery of other systems or severe trauma within 2 months ago; 9. Pregnancy or breast-feeding women; 10. Patients with eurological or psychiatric disorders history including epilepsy or dementia were lack of treatment compliance; 11. Other situations in which investigators thought the patients not suit to be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (adverse events);major pathologic response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival (OS);progression-free survival (PFS);overall survival (OS);Quality of Life;R0 resection; | — |
Countries
China
Contacts
Public ContactGening Jiang
Department of Thoracic Surgery, Shanghai Pulmonary Hospital Tongji University
Outcome results
None listed