Non-small Cell Lung Cancer
Conditions
Interventions
A:Anlotinib
B:Anlotinib
C:Anlotinib
Sponsors
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathology diagnosed with stage IV NSCLC with no driver oncogene who have failed for second lines of therapy; Pathology diagnosed with stage IV NSCLC with EGFR mutation positive and T790M negative who had rapid progression after first-line targeted therapy and not wiling to accept chemotherapy; or stage IV NSCLC with EGFR mutation positive patients who had progression after second-line targeted therapy; 2. Have measurable lesions and the initial evaluation should be done within 4 weeks before study begins; 3. ECOG PS 0-2; 4. If patients have symptomatic brain metastasis, they should have undergone local treatment (surgery or radiotherapy) and have no further treatment plan; 5. Aged=18 years; 6. Life expectancy of more than 12 weeks; 7. Main organs function is normal based on laboratory results in 7 days before study begins: AST/ALT=2.5ULN (=5ULN in liver metastasis); Serum total bilirubin=1.5ULN; ANC=1500/µL; PLT=80,000/ul; Hb=8.0 g/dl; CCr=50ml/min (Cockroft-Gault formula).
Exclusion criteria
Exclusion criteria: 1. Patients with severe cardiovascular diseases: (1) have any of the following conditions 12 months before enrollment: severe unstable myocardial ischemia or myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, severe mitral stenosis; (2) arrhythmia = 2 degrees according to NCI-CTCAE criteria or any level of atrial fibrillation or QT interval prolongation (male>45mm, female>47mm); (3) hypertension that cannot be controlled (blood pressure>150/90mmHg) by two antihypertensive drugs; 2. Patients with severe respiratory diseases: (1) have any of the following conditions 12 months before enrollment: bronchiectasis, chronic obstructive pulmonary disease or lung abscess; 3. Severe active infections (>level 2 infection according to NCI-CTCAE, version 3.0); 4. Epilepsy patients who need medication; 5. Severe tendency of hemorrhage or coagulation disorders; 6. 4 weeks before enrollment, patients appeared NCI-CTCAE grading=2 pulmonary hemorrhage; 7. 4 weeks before enrollment, patients appeared NCI-CTCAE grade=3 other parts of bleeding; 8. Patients failed to heal wounds or ulcers or fractures for long-term; 9. Patients get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep venous thrombosis, and pulmonary embolism; 10. Patients have other kinds of treatment-naive malignancies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWANG YAN
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed