Non-small cell lung cancerNon
Conditions
Interventions
O:Osimertinib therapy
O+A:Osimertinib+anlotinib therapy
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the clinical study and sign the written informed consent; 2. Aged 18 to 75 years, male and female; 3. Patients with stage ? (AJCC 8) non-small cell lung cancer who cannot be surgically treated and who cannot receive radical concurrent chemoradiotherapy; 4. Untreated patients who have not received previous systemic treatment; 5. At least one repeatable tumor lesion according to RECIST1.1 criteria; 6. Can provide high-throughput oncogene assay reports, including EGFR mutation sites and mutation abundance, or can provide tumor tissue samples for throughput oncogene assay; 7. Pathologically confirmed EGFR mutation, whether accompanied by T790M mutation or not; 8. Expected survival >=3 months; 9. ECOG status score 0-2 points; 10. The level of organ function must meet the following requirements: (1) Hematological indicators: absolute neutrophil count >=1.5x10^9/L, platelet count >=80x10^9/L, hemoglobin >=90 g/L; (2) Liver function: total bilirubin =60ml/min; (4) Coagulation function: INR, PT and APTT were less than 1.5 ULN; (5) The ECG was basically normal; 11. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days prior to the first dosing with negative results. If they have sex with an unsterilized male partner, they must use an acceptable and effective contraceptive method within 120 days from the start of screening until the last dosing; Unsterilized male subjects who have sex with a female partner of reproductive age must use an acceptable and effective contraceptive method within 120 days from the start of screening until the last dose.
Exclusion criteria
Exclusion criteria: 1. Had cancerous meningitis; 2. With active central nervous system (CNS) metastases should be excluded, subjects may participate in the study if their CNS metastasis is adequately treated and if their neurological symptoms return to baseline at least 2 weeks prior to enrollment (except for residual signs or symptoms associated with CNS treatment).In addition, subjects must either be non-corticosteroid subjects or receive a steady or gradually reduced dose of prednisone (or equivalent) =10mg/ day; 3. With active, known or suspected autoimmune diseases were excluded.Subjects with type 1 diabetes, hypothyroidism that requires hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recuperate in the absence of an external trigger are eligible for inclusion; 4. Systemic corticosteroids (doses equivalent to >10 mg prednisone/day) or other immunosuppressive agents, subjects receiving inhaled or topical corticosteroids and adrenal corticosteroid replacement therapy were given doses equivalent to >Subjects at 10 mg prednisone/day without active autoimmune disease may participate in the study; 5. Have previously received EGFR or EGFR receptor targeted drug therapy, such as gefitinib, erlotinib, ectinib, afatinib, dactinib, etc.; 6. Have previously received VEGF or VEGF receptor targeted drug therapy, such as bevacizumab, apatinib, etc.; 7. Have coagulation dysfunction or bleeding tendency, or have a history of thrombosis or hemorrhagic disease; 8. Receiving anticoagulant or thrombolytic therapy; 9. There are unhealed wounds, ulcers or fractures; 10. Positive hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCAB) indicates acute or chronic infection; 11. Active pulmonary tuberculosis (TB) infection was determined by chest X-ray, sputum examination, and clinical physical examination.Patients with a history of active tuberculosis infection within the previous 1 year, even if they have been treated, should also be excluded.Patients with a history of active TB infection more than 1 year ago should also be excluded unless the course and type of anti-TB treatment previously used is demonstrated to be appropriate; 12. With wild-type EGFR, subjects were excluded if the EGFR mutation was negative; 13. Subjects with known ALK translocations were excluded; 14. Pre-existing serious heart disease, including: congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina pectoris, myocardial infarction, severe valvular heart disease, and refractory hypertension; 15. Known to be allergic to oxitinib and amlotinib; 16. Using CYP1A2, CYP3A4, CYP3A5 inhibitors or inducers (e.g., ciprofloxacin, ketoconazole, omeprazole, rifamequan).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR,Objective response rate;Rate of adverse reaction;Plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Countries
China
Contacts
Public ContactLiang Jia'bi
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed