The Study of Apatinib Plus CIK as the Third Line Therapy for Advanced Lung Adenocarcinoma Patients With Wild-Type EGFR

Phase 2

Active, not recruiting

• Conditions: Adenocarcinoma of Lung
• Interventions: Biological: Cytokine-Induced Killer Cells; Drug: Apatinib

• Registration Number: NCT02493582
• Lead Sponsor: The First People's Hospital of Changzhou

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib alone as the third line therapy for advanced lung adenocarcinoma patients with wild-type EGFR

Detailed Description

400 patients with stage IIIB \& IV lung adenocarcinoma who had received surgery and chemotherapy,will be randomly divided into group A（Apatinib plus CIK treatment ) or group B（Apatinib), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2030-07
• Study Completion: 2033-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Histologically or cytologically confirmed Lung adenocarcinoma
• Wld-type EGFR
• Stage IIIB/IV
• Failure to prior chemotherapy
• Life expectancy of more than 3 months
• Tissue sample desired for genomic study
• Age ≥ 18 years
• Performance status (WHO) < 3
• Adequate bone marrow function (absolute neutrophil count>1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
• Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
• Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
• Informed consent

Exclusion Criteria

• Lung squamous cell carcinoma or other types of Non-Small cell lung cancer
• Small cell lung cancer
• Have previously received TKIs
• Hemoglobin<8.0 g/dL,White blood cell <3 X 10^9/L;Platelet count <75 X 10^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Pregnant or lactating patients
• Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
• Patients who are suffering from serious autoimmune disease
• Patients who had used long time or are using immunosuppressant
• Patients who had active infection
• Patients who are suffering from serious organ dysfunction
• Patients who are suffering from other cancer
• Other situations that the researchers considered unsuitable for this study.
• Other concurrent uncontrolled illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib+CIK	Cytokine-Induced Killer Cells	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
Apatinib alone	Apatinib	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.
Apatinib+CIK	Apatinib	Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 months

Secondary Outcome Measures

Name	Time	Method
Progression-Free-Survival (PFS)	3 months