Clinical trial NCT02780778: Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Official title: Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: progression-free survival
timeFrame: 1 Day
Secondary outcomes:
measure: objective remission rate
timeFrame: 1 Day
measure: disease control rate
timeFrame: 1 Day
measure: Quality of life score
timeFrame: 1 Day
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: National Clinical Research Center for Cancer of China
name: Zhanyu Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: