Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study (SELECT-2)
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|ClinicalTrials.gov Identifier: NCT04401059|
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma Non-Small-Cell Lung Cancer Adenocarcinoma||Drug: Elemene plus First-generation EGFR-TKIs Drug: First-generation EGFR-TKIs||Phase 4|
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.
In this study, about 22 research centers will participate in. We planned to enroll 468 patients with advanced non-small cell lung adenocarcinoma who were positive for EGFR mutations. The dynamic random method will be adopted in this study. Patients will be randomly divided into the experimental group（Elemene plus First-generation EGFR-TKIs), and control group (First-generation EGFR-TKIs, only). The purpose of this study is evaluating the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer. We also try to analyze the correlation between molecular biomarkers and patient prognosis, including but not limited to drug-resistant genes and circulating tumor cells.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||468 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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): Prospective Study|
|Estimated Study Start Date :||September 20, 2020|
|Estimated Primary Completion Date :||June 14, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Elemene plus First-generation EGFR-TKIs
Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib).
Drug: Elemene plus First-generation EGFR-TKIs
Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day. 3 weeks for a course of treatment, continuous intravenous drip for 2 weeks, followed by 1-week rest. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label.
Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason.
First-generation EGFR-TKIs: refer to the drug label.
Other Name: H10960114, H20010338
Active Comparator: First-generation EGFR-TKIs only
First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib).
Drug: First-generation EGFR-TKIs
refer to the drug label.
Other Name: Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina).
- PFS [ Time Frame: Start of treatment until 1-year follow-up ]PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.
- ORR [ Time Frame: Start of treatment until 1-year follow-up ]ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.
- DCR [ Time Frame: Start of treatment until 1-year follow-up ]Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
- OS [ Time Frame: Start of treatment until 1-year follow-up ]Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive.
- Incidence and severity of AE or SAE [ Time Frame: Start of treatment until 30 days after the last treatment ]
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
- Incidence and severity of ADR or SADR [ Time Frame: Start of treatment until 30 days after the last treatment ]
All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
A SADR is a serious ADR according to the above criteria of SAE.
- Quality of life (QOL) [ Time Frame: Start of treatment until 1-year follow-up ]Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13).
- Karnofsky Performance Scale (KPS) [ Time Frame: Start of treatment until 1-year follow-up ]KPS: Performance status were measured using Karnofsky Performance Scale (KPS)
- Traditional Chinese Medical(TCM) symptoms score [ Time Frame: Start of treatment until 1-year follow-up ]TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness.
- Molecular biomarkers [ Time Frame: Start of treatment until 1-year follow-up ]Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1、MSI-H/dMMR、TMB、HLA、POLE、POLD1、DDR、TP53、KRAS、BRCA2、PBRM1、MDM2/4、EGFR、ALK、PTEN、JAK1/2、DNMT3A、STK11.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401059
|Contact: Tian Xie, PhDfirstname.lastname@example.org|
|Contact: Kaifeng Wang, PhDemail@example.com|
|The Affiliated Hospital of Hangzhou Normal University|
|Hangzhou, Zhejiang, China, 310015|
|Contact: Yongqiang Li, PhD +86-15991099891 firstname.lastname@example.org|
|Principal Investigator:||Ziping Wang, PhD||Beijing Cancer Hospital|