NCT02493582

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
84mo left

Started Jul 2015

Longer than P75 for phase_2

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jul 2015Jul 2033

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

15 years

First QC Date

July 7, 2015

Last Update Submit

February 4, 2016

Conditions

Adenocarcinoma of Lung

Keywords

CIKApatinibLung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    3 months

Secondary Outcomes (1)

  • Progression-Free-Survival (PFS)

    3 months

Other Outcomes (1)

  • Number of participants with Adverse events

    1 month

Study Arms (2)

Apatinib alone

OTHER

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous.

Drug: Apatinib

Apatinib+CIK

EXPERIMENTAL

Apatinib(YN968D1) ,850mg,p.o.,qd,continuous. plus autologous cytokine-induced killer cells 3 cycles,every 1 year,continuous.

Biological: Cytokine-Induced Killer CellsDrug: Apatinib

Interventions

Cytokine-Induced Killer CellsBIOLOGICAL

CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR

Also known as: CIK
Apatinib+CIK
ApatinibDRUG

Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.

Also known as: YN968D1
Apatinib aloneApatinib+CIK

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 9, 2015

Study Start

July 1, 2015

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2033

Last Updated

February 5, 2016

Record last verified: 2016-02