non-small cell lung cancer
Conditions
Interventions
1:irst-line oshitinib sequential chemotherapy and immunotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. Aged > 18 years; 3. Non-small cell lung adenocarcinoma diagnosed histologically or cytologically, genetic testing identified as EGFR gene mutation sensitive (19del or L858R), digital PCR detection without T790M mutation, and before starting the first-line treatment with oshitinib, there are measurable lesions according to RECIST1.1(imaging studies are performed prior to the start of sequential chemotherapy, but measurable lesions may not be present); 4.ECOG score 0-1; 5. Expected survival >= 10 months; 6. Before receiving the first-line treatment of oshitinib, patients had not received systemic chemotherapy or immunotherapy; 7. Patients should have a medical imaging examination report before using oshitinib, and imaging examinations were performed again before sequential chemotherapy was started, and if no disease progression was observed compared with the results obtained 8 months earlier, the patients were rated CR/PR or SD. 8. Systemic corticosteroid administration (prednisone > 10mg/ day or equivalent dose) has been discontinued for at least 2 weeks before enrollment; 9. Major surgery requiring general anesthesia must have been completed for at least 8 weeks before enrollment, and surgery requiring local/epidural anesthesia must have been completed for at least 4 weeks before enrollment; 10. Hemoglobin >= 90g/L (transfusion is not allowed), neutrophils >= 1.5 x 10^9/L (no recombinant human granulocyte colony stimulating factor supportive therapy was used within 14 days prior to detection), and platelets >= 100 x 10^9/L (no recombinant human thrombopoietin or other supportive therapies such as blood transfusion were used within 7 days prior to detection); 11. Serum creatinine = 60mL/min (Cockcroft-Gault formula), and urine protein = 2+ or >= 1.0g/L at baseline, 24-hour quantitative urine protein detection must be <= 1.0g/L before enrollment; 12. Total bilirubin <= 1.5 x ULN (unless confirmed with Gilbert syndrome), AST and ALT <= 2.5 x ULN (AST and/or ALT <= 5 x ULN are allowed in patients with liver metastasis); 13. TSH and FT3/FT4 were in the normal range; 14. Adverse reactions due to previous treatment were returned to level 1 or below before enrollment; 15. Female who were confirmed not pregnant within 7 days before administration, and male or female in the reproductive period should agree to use a medically approved effective contraceptive method throughout the duration of the trial and for a period of 6 months after its completion; 16. Patients were able to follow up regularly, communicate well with the investigator and complete the study in accordance with study regulations.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system (CNS) metastases, including symptomatic brain or meningeal metastases or spinal cord compression; asymptomatic brain metastases may be enrolled (no progression and/or neurological symptoms or signs after surgical resection for at least 4 weeks after radiotherapy and do not require glucocorticoids, antiepileptics, anticonvulsants or mannitol treatment); 2. Patient with a prior history of other malignancies (other than cured carcinoma in situ of the cervix and basal cell carcinoma of the skin) should not be enrolled in the study, unless he/she is in complete remission for at least 2 years before enrollment and does not require any treatment at any time or during the study period; 3. A history of active and known autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, hashimoto's thyroiditis, etc; except type I diabetes, hypothyroidism that can be controlled with hormone replacement therapy alone, skin diseases that require no systemic treatment (such as vitiligo, psoriasis), and controlled celiac disease; 4. Prior treatment with systemic chemotherapy, anti-PD-1 antibody, anti-PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway); 5. Uncontrolled hypertension (systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 90mmHg) or pulmonary hypertension or unstable angina; myocardial infarction or bypass or stent operation within 6 months before administration; a history of grade 3-4 chronic heart failure as defined by the New York Heart Association (NYHA); valvular disease with clinical significance; severe arrhythmias requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interphase >= 450ms in men and >= 470ms in women (calculated by the Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months before administration; 6. Patient with a history of arterial thrombosis or deep vein thrombosis in the first 6 months, or with evidence or history of bleeding tendency in the first 2 months, regardless of severity; partial prothrombin time (APTT) or prothrombin time (PT) > 1.5 x ULN; 7. Skin wound, surgical site, wound site, severe mucosal ulcer or fracture has not been completely healed; 8. Imaging shows evidence of tumor invasion of the great vessels, including complete proximity, inclusion, or invasion of the lumen of the great vessels (e.g., pulmonary artery or superior vena cava); 9. Difficulty in swallowing or known drug absorption; 10. Gastrointestinal disorders or conditions that may cause gastrointestinal bleeding or perforation (e.g., duodenal ulcer, ileus, acute Crohn's disease, ulcerative colitis, large gastrectomy, etc.) that are considered to significantly affect oral drug absorption; patients with chronic Crohn's disease and ulcerative colitis (with the exception of total colon and rectum resection) should be excluded even in the inactive period; patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome; patients with a history of intestinal perforation or intestinal fistula, but failed to recover after surgical treatment; 11. Present or prior history of interstitial pneumonia; 12. Uncontrollable pleural effusion requiring repeated drainage or obvious symptoms; 13. Active infections r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-years PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ADE;QoL; | — |
Countries
China
Contacts
Public ContactQiong Sun
Chinese PLA General Hospital
Outcome results
None listed