NSCLC
Conditions
Interventions
Arm 1:Anlotinib plus docetaxel and cisplatin
Arm 2:docetaxel and cisplatin
Sponsors
The First Affiliated Hospital of Medical University Of Anhui
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily joined the study and signed informed consent with good compliance and follow-up; 2. Aged 18-75 years male and female; 3. Histologically or cytologically confirmed, locally advanced and / or metastatic IIIB, IIIC or IV NSCLC; 4. EGFR gene detected as positive mutation (L858R/Del 19) and received only one systemic EGFR TKI treatment, T790M negative-mutation was detected in after EGFR TKI treatment; 5. There was at least one target lesion that had not received radiotherapy in the past three months and could be accurately measured in at least one direction (the maximum diameter required to be recorded) by magnetic resonance imaging (MRI) or computed tomography (CT), in which conventional CT (> 20 m m) or spiral CT (> 10 m); 6. ECOG 0-2; 7. Estimated survival time=3 mouths; 8. Participants recovered from damage caused by other treatments (NCI-CTCAE version 4.0 grading 4 weeks); radiotherapy (except local palliative radiotherapy) (> 2 weeks); EGFR TKI (> 2 weeks); 9. The main organs are functioning normally, meeting the following criteria: (1) Routine blood test criteria should be met (no blood transfusion and blood products within 14 days, no G-CSF or other hematopoietic stimulating factors corrected): HB=90 g/L; ANC=1.5×10^9/L; PLT=80×10^9/L; (2) biochemical tests should meet the following criteria: TBIL 45 ml/min (Cockcroft-Gault formula); 10. Women of childbearing age must have taken reliable contraceptive measures or had a pregnancy test (serum or urine) conducted within seven days before enrollment, and the results were negative, and they were willing to use appropriate contraceptive methods during the trial and eight weeks after the last test. For men, consent should be given to appropriate contraception or surgical sterilization during the trial and eight weeks after the last trial.
Exclusion criteria
Exclusion criteria: 1. small cell lung cancer (including small cell lung cancer and non-small cell lung cancer mixed lung cancer); 2. Other drive gene mutations associated with known medications, including but not limited to: ALK gene rearrangement, ROS1 mutation, c-MET, BRAF600E mutation, etc.; 3. Imaging (CT or MRI) showed that the tumor focus was less than 5 mm away from the large vessels, or there was a central tumor invading the local large vessels, or there were obvious cavitary or necrotic lung tumors; 4. History and complications: 1) Active brain metastases, cancerous meningitis, spinal cord compression, or lesions of the brain or PIA meninges found on CT or MRI screening (patients with brain metastases who had completed treatment 28 days before enrollment and had stable symptoms may be enrolled, but no symptoms of cerebral hemorrhage should be confirmed by MRI, CT or venography); 2) The patient is participating in other clinical studies or less than 4 weeks from the end of the previous clinical study; 3) other active malignancies requiring simultaneous treatment; 4) a history of malignancy. Except for patients with basal cell carcinoma of the skin, superficial bladder, squamous cell carcinoma of the skin, or carcinoma of the cervix in situ, who had undergone possible curable treatment and had no recurrence within five years after the initiation of self-treatment; 5) Patients who had not recovered to NCI-CTCAE 1.5 or PT > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy. Note: Low doses of heparin (60,000 to 120,000 U per day for adults) or aspirin (100 mg per day) are allowed for preventive purposes on the premise that the international normalized ratio of prothrombin time (INR) is less than 1.5. 7) renal insufficiency: urine routine indicates urine protein > + +, or 24 hours urine protein is more than 1.0g; 8) patients with poor blood pressure control (systolic blood pressure greater than 150 mmHg, diastolic blood pressure equal to 100 mmHg); 9) Subjects who had undergone major surgery or severe trauma had less than 14 days of surgical or traumatic relief before enrollment; 10) severe acute or chronic infection requiring systemic treatment; 11)Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, arrhythmia with poor control (including QTc interval (> 450 ms in males, 470 MS in females), grade III-IV cardiac insufficiency according to NYHA criteria, or left ventricular ejection fraction (LVEF) less than 50% indicated by color Doppler echocardiography; 12) there is a peripheral neuropathy of more than CTCAE 2 degrees, except for trauma; 13) Respiratory syndrome (> CTC AE 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment; 14) long term unhealed wounds or fractures; 15) diabetes with poor glycemic control or other prohibition with high-dose glucocorticoid treatment; 16) There are obvious factors affecting oral drug absorption, such as dysphagia, chronic diarrhea and intestinal obstruction; 17) Significant hemoptysis (hemoptysis more than 50 ml per day) occurred within the first three months of admission, or bleeding symptoms with significant clinical significance or a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;safety; | — |
Countries
China
Contacts
Public ContactGu Kangsheng
Oncology Department of the First Affiliated Hospital of Medical University Of Anhui
Outcome results
None listed