Non-small cell lung cancer
Conditions
Interventions
Group 1:Anlotinib
Group 2:Cisplatin plus docetaxel
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. Pathologically diagnosed as late (IIIB/IIIC/IV) non-small cell lung cancer; 3. Patients with non-T790M EGFR mutation only received 1 EGFR TKI regimen; 4. In the past three months, there was at least one target lesion that had not received radiotherapy, and in at least one direction (the maximum diameter needed to be recorded) it could be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT), in which conventional CT (> 20 mm) or spiral CT (> 10 mm); 5. expected survival time =3 months; 6. ECOG PS score 0–2; 7. AEs caused by other treatments was restored (NCI-CTCAE version 4.0 grading < grade 1), in which the interval of receiving nitrosourea or mitomycin was more than 6 weeks; other cytotoxic drugs, bevacizumab, radiotherapy (except local palliative radiotherapy) or surgery was more than 4 weeks; EGFR TKI molecular targeted drugs were more than 2 weeks; 8. Major organ functions were normal; 9. Women of childbearing age should agree to the usage of contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study, the serum or urine test is negative within 7 days prior to the study, and should be non-lactating patients. Males should agree to the usage of contraceptives during the study and within 6 months after the end of the study period; 10. Subjects volunteered to join the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 2. Patients who were tested positive for EGFR mutations but did not use the relevant targeted drug; 3. Recurrent or metastatic patients who had received more than one single systemic chemotherapy or immunotherapy Patient; 4. Central type, with empty lung squamous cell carcinoma or non-small cell lung cancer with hemoptysis (>50 mL/day); 5. Other malignancies within 5 years or simultaneously, cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor except [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltration basement membrane)]; 6. systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or 6 weeks prior to administration of the test drug) was planned within 4 weeks prior to or during this study. Intravenous radiotherapy (EF-RT) was performed 4 weeks prior to grouping or restricted radiotherapy for assessing tumor lesions within 2 weeks before grouping; 7. non-mitigated toxicity higher than CTC AE level 1, except hair loss due to any previous treatment; 8. patients have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 9. pleural effusion or ascites, causing respiratory syndrome (=CTC AE level 2 dyspnea); 10. patients with brain metastasis have symptoms or controlled symptoms for 10 mmol/L]; h) urine routine test protein = ++, and confirmed 24-h urine protein >1.0 g; i) patients experiencing seizure and need treatment; 12. received a major surgical treatment within 28 days prior to grouping, with a biopsy or a significant traumatic injury; 13. imaging shows that the tumor has violated important vascular weeks or the researchers determine that the tumor is likely to invade critical blood vessels by fatal bleeding during the follow-up study; 14. irrespective of severity, patients show any signs of bleeding or medical history; in the first 4 weeks before the group, patients have any bleeding or bleeding events (=CTCAE 3) with non-healing wounds, ulcers, or fractures; 15. active/venous thrombotic events occurred within 6 months of cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, and pulmonary embolism; 16. patients with a history of mental illness or have mental disorders; 17. any contraindications for cisplatin and docetaxel treatment 18. anaphylaxis to Anlotinib Hydrochloride or excipients in test drugs; 19. allergic reaction to contrast medium. 20. participated in other anti-tumor dru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;ORR;DCR;Qol;AE; | — |
Countries
China
Contacts
Public ContactFeng Jifeng
Jiangsu Cancer Hospital
Outcome results
None listed