Clinical trial NCT04397432: Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study
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）：Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Elemene, TKI, EGFR, Real world study
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
Collaborators: name: LinkDoc Technology (Beijing) Co. Ltd.
First posted: 2020-05-21
Enrollment: 878
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: OS
timeFrame: June 2021
Secondary outcomes:
measure: PFS
timeFrame: June 2021
measure: ORR
timeFrame: June 2021
measure: DCR
timeFrame: June 2021
measure: KPS score
timeFrame: June 2021
measure: ECOG score
timeFrame: June 2021
measure: Incidence and severity of AE or SAE
timeFrame: Start of treatment until 30 days after the last dose.
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Panjin
country: China
facility: Panjin Central Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shenyang Tenth People's Hospital
state: Liaoning
city: Jincheng
country: China
facility: The Second People's Hospital of Yangcheng County
state: Shanxi
city: Chendu
country: China
facility: Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Xiaoshan Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Hangzhouwan Hospital
state: Zhejiang
city: Beijing
country: China
facility: Dongfang Hospital Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Cancer Hospital of Huanxing Chaoyang District Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Ziping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: