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
1 other identifier
observational
878
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
August 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedDecember 27, 2023
December 1, 2023
2.7 years
May 18, 2020
December 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
PFS
June 2021
ORR
June 2021
DCR
June 2021
KPS score
June 2021
ECOG score
June 2021
- +1 more secondary outcomes
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- Histologically or cytologically confirmed advanced non-small cell lung cancer(stage IIIB\~IV).
- Patients with EGFR mutation.
- Received EGFR-TKIs at least once.
- Received Elemene Injectable Emulsion and/or Elemene Oral Emulsion at least once ( only for Elemene plus TKIs group).
- Completeness of important outcome measures and medical records related to the study.
You may not qualify if:
- Accompanied by other active tumors.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tian Xielead
- LinkDoc Technology (Beijing) Co. Ltd.collaborator
Study Sites (19)
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Panjin Central Hospital
Panjin, Liaoning, China
Shenyang Tenth People's Hospital
Shenyang, Liaoning, 110000, China
The Second People's Hospital of Yangcheng County
Jincheng, Shanxi, China
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang, China
Hangzhouwan Hospital
Ningbo, Zhejiang, China
Dongfang Hospital Beijing University of Chinese Medicine
Beijing, 100078, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Cancer Hospital of Huanxing Chaoyang District Beijing
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, China
Tianjin Medical University General Hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziping Wang, PhD
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 21, 2020
Study Start
August 28, 2020
Primary Completion
April 30, 2023
Study Completion
March 30, 2026
Last Updated
December 27, 2023
Record last verified: 2023-12