Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study (SELECT-1)

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）：Retrospective Study

This is a nationwide, multicenter and retrospective 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung

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.

The study is a real-world study and the case records of patients with advanced non-small cell lung cancer who visited the research centers from January 2014 to December 2017 and met the inclusion criteria will be collected. Medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.

• Study Type: Observational
• Enrollment (Actual): 878

Contacts and Locations

• Study Contact: Name: Tian Xie, PhD; Phone Number: +86-13606707928; Email: xbs@dljg.sina.net
• Study Contact Backup: Name: Xinbing Sui, PhD; Phone Number: +86-13486192868; Email: hzzju@zju.edu.cn

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China, 100078
    • Dongfang Hospital Beijing University of Chinese Medicine
  • Beijing, China
    • Cancer Hospital of Huanxing Chaoyang District Beijing
  • Chongqing, China
    • Chongqing University Cancer Hospital
  • Shanghai, China
    • Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
  • Shanghai, China
    • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Tianjin, China
    • Tianjin Academy Of Traditional Chinese Medicine Affiliated Hospital
  • Jiangsu
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
  • Liaoning
    • Panjin, Liaoning, China
      • Panjin Central Hospital
    • Shenyang, Liaoning, China, 110000
      • Shenyang Tenth People's Hospital
  • Shanxi
    • Jincheng, Shanxi, China
      • The Second People's Hospital of Yangcheng County
  • Sichuan
    • Chendu, Sichuan, China
      • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China
      • Zhejiang Xiaoshan Hospital
    • Hangzhou, Zhejiang, China
      • Hangzhou Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Tongde Hospital of Zhejiang Province
    • Ningbo, Zhejiang, China
      • Hangzhouwan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced non-small cell lung cancer and EGFR mutation who visited the research centers from January 2014 to December 2017 and received TKIs therapy with or without Elemene.

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB~IV).
2. Patients with EGFR mutation.
3. Received EGFR-TKIs at least once.
4. Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
5. Completeness of important outcome measures and medical records related to the study.

Exclusion Criteria:

1. Accompanied by other active tumors.
2. The researchers did not consider it appropriate to participate in this study for other reasons.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Elemene plus TKIs; This is a real-world study, we just record the patient's medication who used Elemene Injectable Emulsion and/or Elemene Oral Emulsion plus TKIs. First, second or third generation TKIs were all available, such as Erlotinib, Gefitinib, Icotinib, Afatinib, Dacomitinib, and Osimertinib.
TKIs only; This is a real-world study, we just record the patient's medication who used TKIs only. First, second or third generation TKIs were all available, such as Erlotinib, Gefitinib, Icotinib, Afatinib, Dacomitinib, and Osimertinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS was defined as the interval from the date of the administration of the first-dose TKIs to date of death from any cause, or the date of last known follow-up alive.	June 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	PFS was defined as the interval from date of the administration of the first-dose TKIs to the date of first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.	June 2021
ORR	ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.	June 2021
DCR	Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.	June 2021
KPS score	Performance status were measured by Karnofsky Performance Scale (KPS).	June 2021
ECOG score	Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.	June 2021
Incidence and severity of AE or SAE	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.	Start of treatment until 30 days after the last dose.

Collaborators and Investigators

• Sponsor: Tian Xie
• Collaborators: LinkDoc Technology (Beijing) Co. Ltd.
• Investigators: Principal Investigator: Ziping Wang, PhD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2020
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Elemene, TKI, EGFR, Real world study
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: HangzhouNU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No