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Non Small Cell Lung CancerPhase 2NCT03123484

β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant NSCLC

A Phase 2 study testing β-elemene and EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) in people with Non Small Cell Lung Cancer, run by China Medical University, China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
β-elemene and EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Apr 2017to Oct 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Liu yunpeng, PhD contact

86 24 83282312

cmu_trial@126.com

jin bo, PhD contact

86 24 83282542

jb_cmu@126.com

About this study

Official title: β-elemene Combine With EGFR-TKI for Advanced EGFR-TKI-resistant Non-Small Cell Lung Cancer

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.

Read the detailed description

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. Beta-elemene, a natural plant drug extracted from Curcuma wenyujin, has been used as an antitumor drug for different tumors, including NSCLC via mechanism that inhibits Ras/Mapk signaling and cell cycle progression.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.

main objectives: progression-free survival (PFS) ratio in 12 week the secondary goal: Objective Response Rate （ORR）

Being tested
β-elemene, EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
Keywords
beta-elemene
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • β-elemeneDrug

    Also called elemene liposomes

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

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

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

Study groups in NCT03123484
Study groupRoleWhat they receive
β-elemene+EGFR TKIExperimentalEGFR-TKIs(Erlotinib, Gefitinib and Icotinib) and β-elemene
Receives: Drug: β-elemene; Drug: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
EGFR TKIActive comparatorEGFR-TKIs(Erlotinib, Gefitinib and Icotinib)
Receives: Drug: EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS ratio in 12 week

    progression free survival ratio in 12 week

    Measured: 12 week

Secondary outcomes (1)

  1. OR Rate

    Objective Response Rate

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionApr 2019 (estimated)
  4. Study completionOct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03123484
Sponsor's protocol ID
CLOG1702
Status last verified
Apr 2017
First submitted
5 Apr 2017
Last updated
21 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23944083

  • 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.

    PubMed 23397083

  • 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.

    PubMed 22150682

  • 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.

    PubMed 28341110

  • 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.

    PubMed 28325254

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing β-elemene and EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) in people with Non Small Cell Lung Cancer, run by China Medical University, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liu yunpeng, PhD (86 24 83282312, cmu_trial@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS ratio in 12 week (time frame: 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123484, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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