drugset / Trial / NCT03123484
β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant NSCLC
Phase 2
Unknown
80 enrolled
China Medical University, China
General Hospital of Shenyang Military Region · collabLiaoning Cancer Hospital & Institute · collabShengjing Hospital · collabThe First Affiliated Hospital of Dalian Medical University · collabThe Second Affiliated Hospital of Dalian Medical University · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Epidermal Growth Factor Receptor tyrosine-kinase inhibitors (EGFR-TKIs), including gefitinib,erlotinib and icotinib demonstrate excellent effect on the treatment of non small cell lung cancer (NSCLC) patients with EGFR mutations. However, patients who are initially sensitive to the drugs eventually become resistance. In this study, the investigators aim to explore the efficacy of beta-elemene, combining with EGFR-TKI in advanced non-small cell lung cancer with EGFR-TKI resistance.
Timeline
- Start
- 2017-04
- Primary completion
- 2019-04
- Completion
- 2019-10
Publications
- Background Xu XW, Yuan ZZ, Hu WH, Wang XK. [Meta-analysis on elemene injection combined with cisplatin chemotherapeutics in treatment of non-small cell lung cancer]. Zhongguo Zhong Yao Za Zhi. 2013 May;38(9):1430-7. Chinese.
- Background Li QQ, Wang G, Huang F, Li JM, Cuff CF, Reed E. Sensitization of lung cancer cells to cisplatin by beta-elemene is mediated through blockade of cell cycle progression: antitumor efficacies of beta-elemene and its synthetic analogs. Med Oncol. 2013 Mar;30(1):488. doi: 10.1007/s12032-013-0488-9. Epub 2013 Feb 9.
- Background Liu J, Hu XJ, Jin B, Qu XJ, Hou KZ, Liu YP. beta-Elemene induces apoptosis as well as protective autophagy in human non-small-cell lung cancer A549 cells. J Pharm Pharmacol. 2012 Jan;64(1):146-53. doi: 10.1111/j.2042-7158.2011.01371.x. Epub 2011 Oct 27.
- Background Matsuoka H, Kaneda H, Sakai K, Koyama A, Nishio K, Nakagawa K. Clinical Response to Everolimus of EGFR-Mutation-Positive NSCLC With Primary Resistance to EGFR TKIs. Clin Lung Cancer. 2017 Jan;18(1):e85-e87. doi: 10.1016/j.cllc.2016.08.004. Epub 2016 Oct 4. No abstract available.
- Background Passiglia F, Listi A, Castiglia M, Perez A, Rizzo S, Bazan V, Russo A. EGFR inhibition in NSCLC: New findings.... and opened questions? Crit Rev Oncol Hematol. 2017 Apr;112:126-135. doi: 10.1016/j.critrevonc.2017.02.009. Epub 2017 Feb 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | β-elemene | Unknown | 400 mg | Intravenous |
| Subject | β-elemene | Unknown | 600 mg | Intravenous |
| Background | Erlotinib | Small molecule | — | — |
| Background | Gefitinib | Small molecule | — | — |
| Background | Icotinib | Small molecule | — | — |