non-small cell lung cancer
Conditions
Interventions
single arm guoup:Third generation TKI inhibitor combined with anlotinib
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. They voluntarily participated in the clinical study and signed the written informed consent. 2. They are 18-75 years old, male and female. 3. Patients with histologically confirmed stage IV (AJCC 8) non-small cell lung cancer who cannot be treated surgically and who cannot receive radical concurrent chemoradiotherapy. 4. Newly treated patients who have not received systemic treatment before. 5. According to recist1.1, there should be at least one tumor that can be measured repeatedly. 6. It can provide high-throughput tumor gene detection reports including EGFR mutation sites and mutation abundance, or provide tumor tissue samples for flux tumor gene detection. 7. EGFR mutation was confirmed by pathology, regardless of T790M mutation; 8. The expected survival time was more than 3 months; 9. ECOG status score was 0-2; 10. Organ function level must meet the following requirements: (1) Hematological indexes: neutrophil count >= 1.5 * 10^9 / L, platelet count >= 80 * 10^9 / L, hemoglobin >= 90 g / L; (2) Liver function: total bilirubin = 60ml / min; (4) Blood coagulation function: INR, Pt and APTT <= 1.5 times the upper limit of normal value; (5) The ECG was basically normal. 11. Women of childbearing age must have serum pregnancy test within 3 days before the first administration and the results are negative. If they have sex with non sterile male partners, they must take effective contraceptive methods from the beginning of screening to 120 days after the last administration; the samples of non sterile male subjects who have sex with their partners of childbearing age must be collected from the beginning of screening to 120 days after the last administration take an acceptable and effective contraceptive method.
Exclusion criteria
Exclusion criteria: Subjects who met any of the following exclusion criteria were not eligible for this study: 1. The subjects had cancerous meningitis. 2. Subjects with active central nervous system (CNS) metastasis should be excluded. Subjects with CNS metastases can participate in the study if their CNS metastases can be adequately treated and their neurological symptoms can return to baseline levels at least 2 weeks before enrollment (except for residual signs or symptoms related to CNS treatment). In addition, the subjects had to be those who did not use corticosteroids or received prednisone (or equivalent) with a stable or gradually reduced dose of 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment. Subjects who received inhaled or topical corticosteroids, and those who received corticosteroid replacement therapy with a dose equivalent to > 10 mg prednisone / day, could participate in the study if they did not have active autoimmune diseases. 5. Patients who have been treated with EGFR or EGFR receptor targeted drugs in the past, such as gefitinib, erlotinib, icotinib, afatinib, dacitinib, etc. 6. Patients who have been treated with VEGF or VEGF receptor targeted drugs, such as bevacizumab and apatinib; 7. Have coagulation dysfunction or bleeding tendency, or have a history of thrombosis or hemorrhagic diseases; 8. Those who are receiving anticoagulant or thrombolytic therapy; 9. There were unhealed wound ulcers or fractures; 10. Positive HBsAg or HCAB indicates acute or chronic infection. 11. According to the chest X-ray examination, sputum examination and clinical physical examination, the active tuberculosis (TB) infection was judged. Patients with a history of active tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active tuberculosis infection more than one year ago should also be excluded, unless it is proved that the course and type of anti tuberculosis treatment used before are appropriate. 12. Subjects with EGFR wild type were excluded. EGFR mutation status must be detected in non squamous cell carcinoma subjects whose EGFR mutation status is unknown (PCR based detection is strongly recommended). If EGFR mutation was negative, subjects were excluded. 13. Subjects with known ALK translocation were excluded. 14. Previously severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and intractable hypertension. 15. Those who are known to be allergic to the third generation of TKI inhibitors and anlotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall Survival;Progress Free Survival; | — |
Countries
China
Contacts
Public ContactLin zhong
Department of Thoracic Oncology, The Fifth Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed