non-small cell lung cancer (NSCLC)
Conditions
Interventions
Case series:SHR-1210 in combination with apatinib
Sponsors
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fully understand this study and voluntarily sign the informed consent form (ICF); 2. Ages 18 to 75, regardless of gender; 3. Advanced or recurrent stage III B-C or IV non-small cell lung cancer (according to the AJCC 8th edition staging system) diagnosed by histology and / or cytology with sensitive EGFR mutations, and also meet the following conditions: The previous generation or second generation of EGFR-TKI (including gefitinib, erlotinib, ectinib, and afatinib, etc.) progressed rapidly after treatment and had a negative T790M mutation in exon 20 or a T790M mutation in exon 20 Positive, and then progressed again after receiving oxitinib or other three generations of EGFR-TKI; Participants who failed previous histidine TKI therapy (as first-line therapy) met the inclusion criteria (regardless of their EGFR T790M mutation status); 4. It is allowed to receive neoadjuvant / adjuvant chemotherapy in the early stage, and disease recurrence or metastasis occurs more than 6 months after the last dose of chemotherapy is completed. Note: The elution period of TKI for all participants is 1 week or 2 half-life from the last treatment, whichever is longer. If the subject has other sensitive mutations (except for exon 19 deletion mutation and exon 21 L858R mutation), including: 18G719X, 20S786I, 21L861Q mutations, in addition to meeting the above conditions, the subject needs the subject's previous EGFR -TKI treatment has remission after subsequent failure of TKI treatment. The rapid progress of the disease after TKI treatment in all subjects must be confirmed by the research physician based on the evaluation criteria of the clinical progress model; 5. At least one measurable lesion (according to RECIST 1.1); Note: A lesion that has been previously treated with radiotherapy cannot be considered a target lesion unless the lesion has a clear progression after radiotherapy 6. It is agreed to provide previously stored tumor tissue specimens after failed EGFR-TKI treatment or fresh biopsy tumor lesion tissues, and the relevant pathology reports of the above specimens must be provided. Note: Tumor tissue samples have been provided or newly obtained (no antitumor treatment after biopsy) tumor core tissues have not been previously irradiated. Formalin-fixed paraffin-embedded tissue blocks are superior to slides, and newly obtained biopsies take precedence over archived tissues; 7. According to the Eastern Cooperative Oncology Group (ECOG) standard, the physical fitness score is 0-2; 8. Expected survival >=3 months; 9. Good organ function: Blood routine examination: (without blood transfusion, without G-CSF, without medication correction within 14 days before screening) Hemoglobin (HB) >=90 g/L; Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet count (PLT) >=100x10^9/L; White blood cell count (WBC) 4.0x10^9/L to 15x10^9/L; Biochemical examination: (no blood transfusion or albumin within 14 days before screening); AST and ALT =30 g/L; Cr=60 mL/min (Cockcroft--Gault formula); APTT<=1.5 ULN, while INR or PT<=1.5 ULN (not receiving anticoagulant therapy); 10. Adverse events caused by any previous treatment, surgery, or radiation must have been alleviated to level 0 or 1 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events
Exclusion criteria
Exclusion criteria: 1. History of allogeneic organ transplantation; 2. Active or previously recorded autoimmune or inflammatory diseases (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, Or Wegener syndrome [granulomatous vasculitis, Graves disease, rheumatoid arthritis, pituitary inflammation, uveitis, etc.]) Exceptions to this standard include: patients with vitiligo or hair loss, but on the premise that after consulting a research doctor, patients with coeliac disease that can be controlled by diet alone 3. Uncontrolled concurrent diseases, including but not limited to: persistent or active infections (tuberculosis, HBV / HCV, pneumonia, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, Uncontrolled arrhythmias, active ILD, severe chronic gastrointestinal disorders with diarrhea, or psychosis that may limit compliance with study requirements, cause a significant increase in AE risk, or affect subjects' ability to provide written informed consent / Social situation; 4. Subjects are being treated with immunosuppressive agents, or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose> 10mg / day prednisone or other equivalent hormones), and within 2 weeks before enrollment Still in use; 5. Excessive allergic reactions to other monoclonal antibodies; 6. Imaging (CT or MRI) shows that the tumor invades large blood vessels or the boundary between them is unclear; 7. Imaging (CT or MRI) shows obvious cavity hollow or necrotic tumors; 8. Marginal adenocarcinoma with cavities can be considered after consultation and consultation; 9. Ascites or pleural effusions with clinical symptoms require therapeutic puncture or drainage; 10. If there is obvious coughing blood in the first 2 months of randomization, or the amount of hemoptysis is half a teaspoon (2.5ml) or more; 11. Have had clinically significant bleeding symptoms or have a clear bleeding tendency within the first 3 months of randomization, such as gastrointestinal bleeding, bleeding gastric ulcer, or suffering from vasculitis; 12. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within the first 6 months of randomization; 13. Patients with interstitial lung disease and symptoms of the disease; researchers believe that subjects with a previous lung history that may interfere with the judgment or treatment of drug-related pulmonary toxicity also need to be excluded; 14. Those who have used other drugs in clinical trials to study drugs within 4 weeks before the first use; 15. The subject has suffered from other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ); 16. Subjects may receive other systemic anti-tumor treatments during the study period; 17. In patients with bone metastases, the area of ??palliative radiotherapy received within 4 weeks before participating in the study is> 5% bone marrow area; 18. The subject has previously received other PD-1 antibody therapy or other immunotherapy against PD-1 / PD-L1; 19. Live vaccines may be given less than 4 weeks before the study medication or possibly during the study period; 20. According to the researcher's judgment, the subject has other factors that may lead to the termi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Safety; | — |
Countries
China
Contacts
Public ContactProfessor Liu Li, Associate Professor Meng Rui
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed