NCT02621333

Brief Summary

This is a prospective, randomized, open, multicenter phase Ⅱ study to evaluate the efficacy of cytokine-induced killer cells combined chemotherapy in stage Ⅳ naive EGFR wild-type lung adenocarcinoma.

Trial Health

57
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Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 12, 2021

Status Verified

February 1, 2020

Enrollment Period

2.9 years

First QC Date

November 25, 2015

Last Update Submit

May 10, 2021

Conditions

Lung Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • overall survival time

    overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months

    from the day of randomization to the day of death, up to 36 months

Secondary Outcomes (2)

  • time to progression

    from the day of randomization to the day of first detecting progression, up to 24 months

  • objective response rate

    one year

Study Arms (2)

CIK combined chemotherapy group

EXPERIMENTAL

autologous CIK combined chemotherapy group Drugs: platinum combined doublets; After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-indued killer cells are transfused into the vein of patients in one hour.

Biological: CIKDrug: chemotherapy

chemotherapy group

ACTIVE COMPARATOR

platinum combined doublets Drugs: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/ m2，D1-3 or carboplatin AUC=5, D1.

Drug: chemotherapy

Interventions

CIKBIOLOGICAL

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.

Also known as: autologous cytokine-induced killer cells
CIK combined chemotherapy group
chemotherapyDRUG

platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.

Also known as: platinum combined doublets
CIK combined chemotherapy groupchemotherapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as stage Ⅳ naive EGFR wild-type lung adenocarcinoma by image, tissue and/or cytology; or relapse after operation (if the patient received adjuvant chemotherapy and the interval between the last chemotherapy and relapse is at least six months. The detection method of EGFR mutation is ARMS.
  • EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
  • There should be at least one measurable lesions (by CT or MRI)
  • No other cancer history ( except skin squamous cell carcinoma after surgery)
  • Age between 18 and 75 years old
  • World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
  • Life expectancy more than 3 months and can be followed-up
  • Patients must have adequate organ and marrow functions as defined below: white blood cells: more than 3.5×109/L, Neutrophils: more than 1.5×109/L, Platelets: more than 80×109/L, Hemoglobin more than 90g/L, Serum total bilirubin less than 1.5 folds of the upper normal limit (ULN), Serum glutamic-oxal
  • (o) acetic transaminase: less than 2.5×ULN (if there is liver metastasis less than 5×ULN); Serum creatinine: less than 1.0×ULN, Prothrombin time, Active partial thromboplastin time, Fibrinogen, Thrombin time are in normal ranges.
  • Women of child-bearing period must take effective contraceptive measures during all the time of study. During the period of study the results of blood and urine pregnancy test should be negative.
  • Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
  • Willing to comply with the ban and constraints for this study protocol specified.
  • Informed consent and willing to participate in this study.

You may not qualify if:

  • Accepted other study drugs 30 days before the beginning of this study.
  • Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
  • Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
  • Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
  • Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not be coped with study treatment and monitoring requirements.
  • Known allergy to any kind of component of study drugs
  • Active rheumatic diseases
  • Organ transplant recipients
  • Poor compliance
  • Pregnant women
  • Lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

Related Publications (4)

  • Li R, Wang C, Liu L, Du C, Cao S, Yu J, Wang SE, Hao X, Ren X, Li H. Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study. Cancer Immunol Immunother. 2012 Nov;61(11):2125-33. doi: 10.1007/s00262-012-1260-2. Epub 2012 May 13.

    PMID: 22581306RESULT

  • Zhong R, Teng J, Han B, Zhong H. Dendritic cells combining with cytokine-induced killer cells synergize chemotherapy in patients with late-stage non-small cell lung cancer. Cancer Immunol Immunother. 2011 Oct;60(10):1497-502. doi: 10.1007/s00262-011-1060-0. Epub 2011 Jun 17.

    PMID: 21681372RESULT

  • Wang S, Wang Z. Efficacy and safety of dendritic cells co-cultured with cytokine-induced killer cells immunotherapy for non-small-cell lung cancer. Int Immunopharmacol. 2015 Sep;28(1):22-8. doi: 10.1016/j.intimp.2015.05.021. Epub 2015 May 23.

    PMID: 26013109RESULT

  • Zhao L, Li W, Wang Z, Yang Y, Zhang Y, Shang Y, Ren X, Gao Q. Survival benefit from RectroNectin-activated cytokine-induced killer cells combined with chemotherapy in advanced EGFR wild-type lung adenocarcinoma. Immunotherapy. 2018 Mar 1;10(6):501-510. doi: 10.2217/imt-2017-0140.

    PMID: 29562855DERIVED

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Quanli Gao, M.D.

    Henan Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 3, 2015

Study Start

October 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

May 12, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

terminated as the slow enrollment

Locations

CN(1)