This trial is active, not recruiting.

Condition adenocarcinoma of lung
Treatments cytokine-induced killer cells, apatinib
Phase phase 2
Targets VEGF, KIT
Sponsor The First People's Hospital of Changzhou
Start date July 2015
End date July 2030
Trial size 400 participants
Trial identifier NCT02493582, CAA


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.
apatinib YN968D1
Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.
Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.
cytokine-induced killer cells CIK
CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR
apatinib YN968D1
Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.

Primary Outcomes

Overall Survival (OS)
time frame: 3 months

Secondary Outcomes

Progression-Free-Survival (PFS)
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title The Randomized, Controlled Clinical Trial of Apatinib Plus CIK as the Third Line Therapy for Lung Adenocarcinoma Patients With Wild-Type EGFR
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) .
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by The First People's Hospital of Changzhou.