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Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study (SELECT-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401059
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Collaborator:
LinkDoc Technology (Beijing) Co. Ltd.
Information provided by (Responsible Party):
Tian Xie, Hangzhou Normal University

Brief Summary:
This is a nationwide, multicenter and prospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Carcinoma Non-Small-Cell Lung Cancer Adenocarcinoma Drug: Elemene plus First-generation EGFR-TKIs Drug: First-generation EGFR-TKIs Phase 4

Detailed Description:

About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of serious adverse events. However, after a median of 8 to 13 months of disease control, patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown to have a comprehensive anti-tumor effect and the potential effect on reversing drug resistance.

In this study, about 22 research centers will participate in. We planned to enroll 468 patients with advanced non-small cell lung adenocarcinoma who were positive for EGFR mutations. The dynamic random method will be adopted in this study. Patients will be randomly divided into the experimental group(Elemene plus First-generation EGFR-TKIs), and control group (First-generation EGFR-TKIs, only). The purpose of this study is evaluating the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer. We also try to analyze the correlation between molecular biomarkers and patient prognosis, including but not limited to drug-resistant genes and circulating tumor cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Synergistic Real-World Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors(TKIs)in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC): Prospective Study
Estimated Study Start Date : September 20, 2020
Estimated Primary Completion Date : June 14, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Elemene plus First-generation EGFR-TKIs
Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib).
Drug: Elemene plus First-generation EGFR-TKIs

Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day. 3 weeks for a course of treatment, continuous intravenous drip for 2 weeks, followed by 1-week rest. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label.

Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason.

First-generation EGFR-TKIs: refer to the drug label.

Other Name: H10960114, H20010338

Active Comparator: First-generation EGFR-TKIs only
First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib).
Drug: First-generation EGFR-TKIs
refer to the drug label.
Other Name: Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina).




Primary Outcome Measures :
  1. PFS [ Time Frame: Start of treatment until 1-year follow-up ]
    PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.


Secondary Outcome Measures :
  1. ORR [ Time Frame: Start of treatment until 1-year follow-up ]
    ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.

  2. DCR [ Time Frame: Start of treatment until 1-year follow-up ]
    Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.

  3. OS [ Time Frame: Start of treatment until 1-year follow-up ]
    Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive.

  4. Incidence and severity of AE or SAE [ Time Frame: Start of treatment until 30 days after the last treatment ]

    Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

    A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect


  5. Incidence and severity of ADR or SADR [ Time Frame: Start of treatment until 30 days after the last treatment ]

    All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.

    A SADR is a serious ADR according to the above criteria of SAE.



Other Outcome Measures:
  1. Quality of life (QOL) [ Time Frame: Start of treatment until 1-year follow-up ]
    Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13).

  2. Karnofsky Performance Scale (KPS) [ Time Frame: Start of treatment until 1-year follow-up ]
    KPS: Performance status were measured using Karnofsky Performance Scale (KPS)

  3. Traditional Chinese Medical(TCM) symptoms score [ Time Frame: Start of treatment until 1-year follow-up ]
    TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness.

  4. Molecular biomarkers [ Time Frame: Start of treatment until 1-year follow-up ]
    Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1、MSI-H/dMMR、TMB、HLA、POLE、POLD1、DDR、TP53、KRAS、BRCA2、PBRM1、MDM2/4、EGFR、ALK、PTEN、JAK1/2、DNMT3A、STK11.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18.
  2. Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB~IV).
  3. Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) monotherapy for the first time.
  4. Patients positive for EGFR gene mutation, with disease progression after receiving chemotherapy can be enrolled.
  5. Confirmed by investigators, tumor tissue can't be surgically excised.
  6. No prior exposure to other Chinese patent medicine with similar efficacy within one month. If the patients accepted those medicine, after a 30-day washout period (without continuing to use the above medications) can be enrolled.
  7. The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

Exclusion Criteria:

  1. Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment, If metachronous tumors have been controlled, participating was allowed )
  2. Exposure to First-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy.
  3. Receiving radiotherapy or chemotherapy.
  4. Pregnant or lactating women.
  5. Allergic to Elemene.
  6. Participating in other drug clinical trials.
  7. Refuse to comply with the follow-up.
  8. The researchers did not consider it appropriate to participate in this study for other reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401059


Contacts
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Contact: Tian Xie, PhD +86-13606707928 xbs@dljg.sina.net
Contact: Kaifeng Wang, PhD +86-13588088469 kaifengw@aliyun.com

Locations
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China, Zhejiang
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China, 310015
Contact: Yongqiang Li, PhD    +86-15991099891    liyongqiang19701217@126.com   
Sponsors and Collaborators
Tian Xie
LinkDoc Technology (Beijing) Co. Ltd.
Investigators
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Principal Investigator: Ziping Wang, PhD Beijing Cancer Hospital
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Responsible Party: Tian Xie, Professor, Hangzhou Normal University
ClinicalTrials.gov Identifier: NCT04401059    
Other Study ID Numbers: HangzhouNU-2
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tian Xie, Hangzhou Normal University:
Elemene
TKI
EGFR
Real-world study
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action