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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Treatments: Apatinib; Docetaxel

Criteria

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