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Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer (NCT02780778)

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.
  • Drug: Apatinib
    Targeted therapy Apatinib:500 mg,po,qd
    • YN968D1
  • Drug: Docetaxel
    chemotherapy Docetaxel:60mg/m²,vein input 1hour,every 3w
    • Taxotere
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
All
Accepts 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

1 locations

China (1)
  • Tianjin Medical University Cancer Institute and Hospital
    recruiting
    Tianjin, Tianjin, China, 300060
Status:
unknown
Type:
Interventional
Phase:
Ⅱ, Ⅲ
Start:
30 April, 2016
Updated:
18 May, 2016
Participants:
20
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