NCT03123484

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 5, 2017

Last Update Submit

April 18, 2017

Conditions

Non Small Cell Lung Cancer

Keywords

beta-elemene

Outcome Measures

Primary Outcomes (1)

  • PFS ratio in 12 week

    progression free survival ratio in 12 week

    12 week

Secondary Outcomes (1)

  • OR Rate

    12 week

Study Arms (2)

β-elemene+EGFR TKI

EXPERIMENTAL

EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) and β-elemene

Drug: β-elemeneDrug: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)

EGFR TKI

ACTIVE COMPARATOR

EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)

Drug: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)

Interventions

β-elemeneDRUG

β-elemene：400-600mg + 5%GS 500ml,ivgtt,qd, continuously 45days

Also known as: elemene liposomes
β-elemene+EGFR TKI
EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)DRUG

EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) as usual

EGFR TKIβ-elemene+EGFR TKI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obtain of informed consent.
  • Histologically or cytologically confirmed, inoperable, recurrence or metastasis advanced non-small cell lung cancer (TNM Stage ⅢB or stage Ⅳ), took EGFR-TKI longer than 6 months and appeared disease progression.
  • At least one measurable lesion (helical CT scan long diameter ≥10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors（RESCIST） version 1.1).
  • Eastern Cooperative Oncology Group（ECOG）Performance Status（PS） :0-2.
  • Aged from 18 to 75 years (18 and 75 years are included).
  • Life expectancy ≥12 weeks.
  • Adequate bone marrow reserve and organ function as follows:
  • Absolute neutrophils count (ANC) ≥1.5 x 10 to the 9th power/L (band neutrophil and segmented neutrophil), platelets \> 100 x 10 to the 9th power/L and Hb≥90g/L.
  • Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN).
  • Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 times ULN (or less than or equal to 5 times ULN in case of known liver involvement.
  • Renal: Serum Creatinine less than or equal to 1.25 times upper limit of normal (ULN).
  • Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.

You may not qualify if:

  • Do not meet the above criteria.
  • Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery.
  • Symptomatic Central Nervous System (CNS) metastases.
  • Clinical uncontrolled active infection, such as acute pneumonia, active hepatitis B or C (prior hepatitis B history, despite medication treatment control or not, HBV DNA≥500copies or ≥100IU/ml), etc.
  • Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason ≤6).
  • Take part in new drug clinical trials within one month or taking part in a trial now.
  • Pregnant or lactating woman.
  • Other conditions regimented at investigators' discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 23944083BACKGROUND

  • 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.

    PMID: 23397083BACKGROUND

  • 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.

    PMID: 22150682BACKGROUND

  • 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.

    PMID: 28341110BACKGROUND

  • 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.

    PMID: 28325254BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinibicotinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Liu yunpeng, PhD

    Director of Department of Medical Oncology,The First Hospital of China Medical University Affiliation: China Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu yunpeng, PhD

CONTACT

86 24 83282312cmu_trial@126.com

jin bo, PhD

CONTACT

86 24 83282542jb_cmu@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Medical Oncology,The First Hospital of China Medical University Affiliation: China Medical University, China

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 21, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2019

Study Completion

October 1, 2019

Last Updated

April 21, 2017

Record last verified: 2017-04