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

Tianjin Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Docetaxel

Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02780778

AHEAD-HBL0001

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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