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

The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR

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

Study Overview

• Status: Active, not recruiting
• Conditions: Adenocarcinoma of Lung
• Intervention / Treatment: Drug: Apatinib; Biological: Cytokine-Induced Killer Cells

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Apatinib alone; Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.	Drug: Apatinib; Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.; Other Names: YN968D1
Experimental: Apatinib+CIK; Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.	Drug: Apatinib; Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.; Other Names: YN968D1; Biological: Cytokine-Induced Killer Cells; CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR; Other Names: CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-Free-Survival (PFS)	3 months

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse events	1 month

Collaborators and Investigators

• Sponsor: The First People's Hospital of Changzhou

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2030
• Study Completion (Anticipated): July 1, 2033

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Apatinib; Lung Adenocarcinoma; CIK
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: CAA