drugset / Trial / NCT02621333
Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma
Phase 2
Terminated
280 enrolled
Henan Cancer Hospital
150th Hospital of PLA · collabAnyang Regional Hospital · collabFirst Affiliated Hospital of Nanyang Medical College · collabFirst People's Hospital of Shangqiu · collabHebei Medical University Fourth Hospital · collabHenan Provincial People's Hospital · collabJiaozuo Tumor Hospital · collabNanyang Central Hospital · collabPuyang Oilfield General Hospital · collabShanxi Dayi Hospital · collabShenma Medical Group General Hospital · collabTangshan People's Hospital · collabThe 152th Central Hospital of PLA · collabXinyang Central Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2018-09
- Completion
- 2018-09
Outcome
Outcome not reported
Stopped (Enrollment): “As there are so many clinical trials in progress and the number of patients enrolled limited.”
Publications
- Results 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.
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CIK | Cell therapy | 5e+09 cells | Intravenous |
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | — |