Clinical trial · Interventional
Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma
Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma: A Prospective, Randomised, Open, Multicenter Phase Ⅱ Study
NCT02621333CI-TRIAL-00051758terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As there are so many clinical trials in progress and the number of patients enrolled limited.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| CIK | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CIK combined chemotherapy group
- description
- 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.
- interventionNames
- Biological: CIK
- Drug: chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- chemotherapy group
- description
- 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.
- interventionNames
- Drug: chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTLi 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 22581306
- RESULTZhong 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 21681372
- RESULTWang 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 26013109
- DERIVEDZhao 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 29562855