Apatinib, EGFR-TKI, NSCLC
Conditions
Keywords
Apatinib, EGFR-TKI resistance, slowly progress
Brief summary
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.
Detailed description
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.
Interventions
DRUGApatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.
Sponsors
Shenzhen People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions * Electronics Coordinating Grop（ECOG）score：0-2 * Expected survival over 3months * Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）\<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）\<2.5 ULN；Cr≤1.25ULN
Exclusion criteria
* Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）); * Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy); * Hemorrhoid dysfunction (inernational standard ratio(INR)\> 1.5 or prothrombin time (PT)\> ULN + 4 seconds or activated partial thromboplastin(APTT)\> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; * Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like; * Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study; * Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 months | the disease progression free survival of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 8 months | overall survival |
| ORR | 6 months | objective response rates |
Countries
China
Contacts
Primary ContactCAO HUA, MD
Outcome results
None listed