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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Accompanied by other active tumors. The researchers did not consider it appropriate to participate in this study for other reasons.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elemene plus TKIs<br>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<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elemene, TKI, EGFR, Real world study