Non-small Cell Lung Cancer
Conditions
Brief summary
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.
Interventions
DRUGApatinib
Targeted therapy Apatinib：500 mg，po，qd
DRUGDocetaxel
chemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 and ≤ 75 years of age * Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer. * EGFR mutation testing negative of sensitive mutations * At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan) * Have failed for 1 lines of chemotherapy * ECOG performance scale 0 - 1. * Life expectancy of more than 3 months. * Duration from the last therapy is more than 6 weeks for nitroso or mitomycin * More than 4 weeks after operation or radiotherapy * More than 4 weeks for cytotoxic agents * Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10\^9/L, neutrophils ≥ 1.5×10\^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min, * Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
* Received more than one kind of chemotherapy regimens * NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy * Existing therapy related toxicity of prior chemotherapy and/or radiation therapy * Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * Any factors that influence the usage of oral administration * The center of the tumor invaded local large blood vessels * Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3). * Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc. * Less than 4 weeks from the last clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 1 Day |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate | 1 Day |
| disease control rate | 1 Day |
| Quality of life score | 1 Day |
Countries
China
Contacts
Primary ContactZhanyu Pan, Master
Outcome results
None listed