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Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02621333
Recruitment Status : Unknown
Verified December 2015 by Quanli Gao, Henan Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
Henan Provincial People's Hospital
Hebei Medical University Fourth Hospital
Shanxi Dayi Hospital
Tangshan People's Hospital
150th Hospital of PLA
First Affiliated Hospital of Nanyang Medical College
Nanyang Central Hospital
First People's Hospital of Shangqiu
Anyang Regional Hospital
Puyang Oil Field General Hospital
Shenma Medical Group General Hospital
Jiaozuo Tumor Hospital
The 152th Central Hospital of PLA
Xinyang Central Hospital
Information provided by (Responsible Party):
Quanli Gao, Henan Cancer Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Biological: CIK Drug: chemotherapy Phase 2

Detailed Description:
There is still no great improvement in advanced EGFR wild-type lung adenocarcinoma although great progress was made in treatment of non-small cell lung cancer. It's necessary to explore the treatment mode of this kind of patients. As the progress was made in tumor immunity and immunotherapy, more and more cancer therapists accept the treatment model of chemotherapy combined immunotherapy. And now chemotherapy combined autologous CIK cells is one kind of common treatment model in some countries. Investigators try to evaluate the efficacy and safety of this kind of treatment model in patients with stage Ⅳ naive EGFR wild-type lung adenocarcinoma.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase Ⅱ Study
Study Start Date : October 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CIK combined chemotherapy group
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: CIK
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.
Other Name: autologous cytokine-induced killer cells

Drug: chemotherapy
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.
Other Name: platinum combined doublets
Active Comparator: chemotherapy group
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
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.
Other Name: platinum combined doublets


Outcome Measures
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Primary Outcome Measures :
  1. overall survival time [ Time Frame: from the day of randomization to the day of death, up to 36 months ]
    overall survival time aims at from date of randomization until the date of death from any cause, up to 36 months


Secondary Outcome Measures :
  1. time to progression [ Time Frame: from the day of randomization to the day of first detecting progression, up to 24 months ]
    time to progression points to from date of randomization until the date of first documented progression, up to 24 months

  2. objective response rate [ Time Frame: one year ]
    the partion of overall remission in total proportion

  3. quality of life [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. EML4-ALK fuse gene is negative and the detection of EML4-ALK is FISH or ventana IHC.
  3. There should be at least one measurable lesions (by CT or MRI)
  4. No other cancer history ( except skin squamous cell carcinoma after surgery)
  5. Age between 18 and 75 years old
  6. World health organization- Eastern Cooperative Oncology Group Performance Status 0-1
  7. Life expectancy more than 3 months and can be followed-up

  8. 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.

  9. 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.
  10. Men should take effective contraceptive measures from the beginning of therapy to one month after the last cycle of chemotherapy.
  11. Willing to comply with the ban and constraints for this study protocol specified.
  12. Informed consent and willing to participate in this study.

Exclusion Criteria:

  1. Accepted other study drugs 30 days before the beginning of this study.
  2. Brain metastases with clinical symptoms ( with exception of being controlled after radiation)
  3. Active viral or bacterial infection and can't be controlled with appropriate anti-infection treatment
  4. Known as HIV infection, syphilis serology reaction positive, active hepatitis B virus or hepatitis C virus infection
  5. 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.
  6. Known allergy to any kind of component of study drugs
  7. Active rheumatic diseases
  8. Organ transplant recipients
  9. Poor compliance
  10. Pregnant women
  11. Lactating women
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621333


Contacts
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Contact: Quanli Gao, M.D. +86-371 65587795 gaoquanli2015@126.com
Contact: Lingdi Zhao, M.D. +86-371 65587483 lingdi1010@sohu.com

Locations
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China, Henan
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university Recruiting
ZhengZhou, Henan, China, 450008
Contact: Quanli Gao, M.D.    +8615038171966    guaoquanli2015@126.com   
Contact: Lingdi Zhao, M.D.    +8637165587483    lingdi1010@sohu.com   
Principal Investigator: Quanli Gao, M.D.         
Sponsors and Collaborators
Henan Cancer Hospital
Henan Provincial People's Hospital
Hebei Medical University Fourth Hospital
Shanxi Dayi Hospital
Tangshan People's Hospital
150th Hospital of PLA
First Affiliated Hospital of Nanyang Medical College
Nanyang Central Hospital
First People's Hospital of Shangqiu
Anyang Regional Hospital
Puyang Oil Field General Hospital
Shenma Medical Group General Hospital
Jiaozuo Tumor Hospital
The 152th Central Hospital of PLA
Xinyang Central Hospital
Investigators
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Study Director: Quanli Gao, M.D. Henan Cancer Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Quanli Gao, director, Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT02621333    
Other Study ID Numbers: HenanCH003
First Posted: December 3, 2015    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site