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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— SELECT-1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04397432
• Other study ID #: HangzhouNU
• Status: Active, not recruiting
• Start date: August 28, 2020
• Est. completion date: March 30, 2026

Study information

• Verified date: December 2023
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 878
• Est. completion date: March 30, 2026
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Cancer Hospital of Huanxing Chaoyang District Beijing	Beijing
China	Dongfang Hospital Beijing University of Chinese Medicine	Beijing
China	Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital	Chendu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing
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	The Second People's Hospital of Yangcheng County	Jincheng	Shanxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Hangzhouwan Hospital	Ningbo	Zhejiang
China	Panjin Central Hospital	Panjin	Liaoning
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	Shenyang Tenth People's Hospital	Shenyang	Liaoning
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tian Xie	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	DCR	Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.	June 2021
Secondary	KPS score	Performance status were measured by Karnofsky Performance Scale (KPS).	June 2021
Secondary	ECOG score	Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.	June 2021
Secondary	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.