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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02780778
• Other study ID #: AHEAD-HBL0001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 3, 2016
• Last updated: May 19, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2016
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Zhanyu Pan, Master
• Phone: 86-13752570372
• Email: wangcongalex[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Apatinib
Targeted therapy Apatinib:500 mg,po,qd
• Docetaxel
chemotherapy Docetaxel:60mg/m²,vein input 1hour,every 3w

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		1 Day	No
Secondary	objective remission rate		1 Day	No
Secondary	disease control rate		1 Day	No
Secondary	Quality of life score		1 Day	No