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

NCT04401059 | Recruiting Phase 4

• 1 other identifier: HangzhouNU-2
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 7

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.

Conditions

Carcinoma; Non-Small-Cell Lung Cancer; Adenocarcinoma

Keywords

Elemene; TKI; EGFR; Real-world study

Outcome Measures

Primary Outcomes (1)

• PFS

  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.

  Start of treatment until 1-year follow-up

Secondary Outcomes (5)

• ORR

  Start of treatment until 1-year follow-up

• DCR

  Start of treatment until 1-year follow-up

• OS

  Start of treatment until 1-year follow-up

• Incidence and severity of AE or SAE

  Start of treatment until 30 days after the last treatment

• Incidence and severity of ADR or SADR

  Start of treatment until 30 days after the last treatment

Other Outcomes (4)

• Quality of life (QOL)

  Start of treatment until 1-year follow-up

• Karnofsky Performance Scale (KPS)

  Start of treatment until 1-year follow-up

• Traditional Chinese Medical(TCM) symptoms score

  Start of treatment until 1-year follow-up

Study Arms (2)

Elemene plus First or Third generation EGFR-TKIs

EXPERIMENTAL

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).

Drug: Elemene plus first or third generation EGFR-TKIs

First or third generation EGFR-TKIs only

ACTIVE COMPARATOR

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

Drug: First or third generation EGFR-TKIs

Interventions

Elemene plus first or third generation EGFR-TKIs 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.

Also known as: H10960114, H20010338

Elemene plus First or Third generation EGFR-TKIs

First or third generation EGFR-TKIs DRUG

refer to the drug label.

Also known as: Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.

First or third generation EGFR-TKIs only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18.
• Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB\~IV).
• 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).
• 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.
• Confirmed by investigators, tumor tissue can't be surgically excised.
• No prior exposure to elemene injectable and/or oral emulsion within one month.
• 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).
• The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.

You may not qualify if:

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

Sponsors & Collaborators

• Tian Xie: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator

Study Sites (7)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Panjin Central Hospital

Panjin, Liaoning, China

RECRUITING

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

The Second People's Hospital of Yangcheng County

Jincheng, Shanxi, 048100, China

RECRUITING

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

Chengdu, Sichuan, China

RECRUITING

Hangzhou Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Peking University Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Interventions

elemene; aumolertinib; aflutinib

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ziping Wang, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Xie, PhD

CONTACT

+86-13606707928; xbs@dljg.sina.net

Kaifeng Wang, PhD

CONTACT

+86-13588088469; kaifengw@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 26, 2020
• Study Start: November 9, 2020
• Primary Completion: September 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (7)