Lung Cancer
Conditions
Sponsors
Shanxi Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with stage IV NSCLC confirmed by histology or cytology had exon 19 deletion or 21 L858R point mutation; 2. Both male and female patients aged 18 or above; 3. Patients with disease progression after the first and second generation EGFR-TKI (including erlotinib, gefitinib, icotinib, afatinib and dactynib) must have received the third generation EGFR-TKI, ometinib (T790M positive), or the first and second generation EGFR-TKI (including erlotinib, gefitinib, icotinib, afatinib and dactynib) Patients with disease progression after treatment with EGFR-TKI (octetinib) and negative T790M; or patients with disease progression after initial treatment with third generation EGFR-TKI (octetinib); 4. Patients with at least one measurable lesion according to RECIST 1.1; 5. ECOG02 6. Patients whose expected survival time is more than or equal to 12 weeks; 7. The functions of important organs meet the following requirements (it is not recommended to use any blood components and cell growth factors 2 weeks before the start of the study treatment) (1) Absolute neutrophil count (ANC) > 1.5 x 10^9 / L (2) Platelets >= 100 x 10^9 / L; (3) Hemoglobin >= 9g / dl; (4) 8 g / dl; (5) Bilirubin = 50ml / min (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) < 1.5 x ULN (for anticoagulant therapy with stable dose, such as low molecular weight heparin or warfarin, INR can be selected within the expected therapeutic range of anticoagulant); 8. Fertile female subjects should conduct urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to use effective contraceptive methods from the test period to 3 months after the last administration of karelizumab (control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial and within 3 months after the last administration of karelizumab (from the control group to 180 days after the last administration); 9. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up; 10. The researchers determined that the patients could receive the combination therapy of karelizumab.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignant tumors within 5 years before the first use of the study drug, except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical cancer in situ and / or breast cancer after effective treatment; 2. Those patients whose radiologic evidence (CT or MRI) indicates that there is a central tumor invading the local large blood vessels; they have clinically significant hemoptysis in the past 3 months; 3. Patients receiving anticoagulant or antiplatelet drugs; patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) and bleeding tendency; patients with severe thrombosis or clinically related severe bleeding events in the past 6 months; patients with hereditary bleeding or thrombosis tendency; patients with severe thrombotic events in the past 6 months; 4. Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5. Patients with any active autoimmune disease or history of autoimmune disease (e.g. interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (acceptable after hormone replacement therapy)); patients with vitiligo or asthma in childhood have been completely relieved without any intervention in adults Asthma patients who need medical intervention with bronchodilators can not be included; 6. Patients with uncontrollable clinical cardiac symptoms or diseases, such as: (1) heart failure of NYHA grade II or above; (2) unstable angina pectoris; (3) myocardial infarction within one year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7. Patients with known history or evidence of interstitial lung disease or active non infectious pneumonia; 8. Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (hbv-dna2000 IU / ml or >= 104 copies / ml) or hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analytical method); 9. Patients who have received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1 in the past; 10. Patients who are known to be allergic to macromolecular protein preparations or to any component of karelizumab, or have allergic reactions, hypersensitivity or contraindications to any component used in apatinib; 11. Patients with multiple factors affecting oral drug absorption, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc; 12. Patients with major surgery or significant trauma within 28 days before enrollment; 13. Subjects requiring systemic treatment with corticosteroids ( > 10mg / D prednisone equivalent dose) or other immunosuppressants within 14 days before the first use of the study drug; 14. Patients whose toxicity of previous anti-tumor therapy did not return to 140 mmHg, diastolic blood pressure > 90 mmHg); 17. According to the judgment of the researcher, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness) requiring combi
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| safty;OS;PFS;DCR; | — |
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactGuo Wei
Shanxi Tumor Hospital
Outcome results
None listed