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

NCT ID: NCT04401059

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

744 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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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 744 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 or third generation EGFR-TKIs), and control group (First or third 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.

Conditions

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Carcinoma Non-Small-Cell Lung Cancer Adenocarcinoma

Keywords

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Elemene TKI EGFR Real-world study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elemene plus First or Third generation EGFR-TKIs

Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First -generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or Third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).

Group Type EXPERIMENTAL

Elemene plus first or third generation EGFR-TKIs

Intervention Type DRUG

Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. 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 or third generation EGFR-TKIs: refer to the drug label.

First or third generation EGFR-TKIs only

First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).

Group Type ACTIVE_COMPARATOR

First or third generation EGFR-TKIs

Intervention Type DRUG

refer to the drug label.

Interventions

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Elemene plus first or third generation EGFR-TKIs

Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. 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 or third generation EGFR-TKIs: refer to the drug label.

Intervention Type DRUG

First or third generation EGFR-TKIs

refer to the drug label.

Intervention Type DRUG

Other Intervention Names

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H10960114, H20010338 Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.

Eligibility Criteria

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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) or third generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib) monotherapy for the first time (patients who have been using first- or third-generation EGFR-TKIs for less than 28 days can be enrolled).
4. Patients positive for EGFR gene mutation (deletions in exon 19 and L858R in exon 21 of the EGFR gene), 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 elemene injectable and/or oral emulsion within one month.
7. Prior exposure to other Chinese patent medicine with similar efficacy within one month. If more than one month, patients can be enrolled after a 30-day washout period (without continuing to use the above medications).
8. The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

Exclusion Criteria

1. Patients with any EGFR mutations other than 19DEL or 21L858R.
2. Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment， If metachronous tumors have been controlled, participating was allowed )
3. Exposure to First- or third-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy.
4. Receiving radiotherapy or chemotherapy.
5. Pregnant or lactating women.
6. Allergic to Elemene.
7. Participating in other drug clinical trials.
8. Refuse to comply with the follow-up.
9. The researchers did not consider it appropriate to participate in this study for other reasons.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LinkDoc Technology (Beijing) Co. Ltd.

INDUSTRY

Sponsor Role collaborator

Tian Xie

OTHER

Sponsor Role lead

Responsible Party

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Tian Xie

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ziping Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status RECRUITING

Panjin Central Hospital

Panjin, Liaoning, China

Site Status RECRUITING

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The Second People's Hospital of Yangcheng County

Jincheng, Shanxi, China

Site Status RECRUITING

Sichuan Academy of Medical Sciences· Sichuan Province People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Peking University Cancer Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tian Xie, PhD

Role: CONTACT

Phone: +86-13606707928

Email: [email protected]

Kaifeng Wang, PhD

Role: CONTACT

Phone: +86-13588088469

Email: [email protected]

Facility Contacts

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Hongyu Zhao

Role: primary

Role: backup

Qinghua Gao

Role: primary

Qi Li

Role: primary

Bing Wei

Role: primary

Ke Xie

Role: primary

Jiyuan Ding

Role: primary

Ziping Wang

Role: primary

Role: backup

Other Identifiers

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HangzhouNU-2

Identifier Type: -

Identifier Source: org_study_id