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

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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
- 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
- objective response rate [ Time Frame: one year ]the partion of overall remission in total proportion
- quality of life [ Time Frame: one year ]

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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 |
Inclusion Criteria:
- 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
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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.
Exclusion Criteria:
- 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

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
Contact: Quanli Gao, M.D. | +86-371 65587795 | gaoquanli2015@126.com | |
Contact: Lingdi Zhao, M.D. | +86-371 65587483 | lingdi1010@sohu.com |
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. |
Study Director: | Quanli Gao, M.D. | Henan Cancer Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Adenocarcinoma Adenocarcinoma of Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |