SELECT-2
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
Sponsor study identifier
interventional
744
1 country
7
Study Start
November 9, 2020
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a nationwide, multicenter and prospective 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 18, 2020
Actual (reported)May 26, 2020
Actual (reported)November 9, 2020
Actual (reported)September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PFS
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.
Start of treatment until 1-year follow-up
ORR
Start of treatment until 1-year follow-up
DCR
Start of treatment until 1-year follow-up
OS
Start of treatment until 1-year follow-up
Incidence and severity of AE or SAE
Start of treatment until 30 days after the last treatment
Incidence and severity of ADR or SADR
Start of treatment until 30 days after the last treatment
Quality of life (QOL)
Start of treatment until 1-year follow-up
Karnofsky Performance Scale (KPS)
Start of treatment until 1-year follow-up
Traditional Chinese Medical(TCM) symptoms score
Start of treatment until 1-year follow-up
Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First -generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or Third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).
First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).
Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. 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 or third generation EGFR-TKIs: refer to the drug label.
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Panjin Central Hospital
Panjin, Liaoning, China
Ziping Wang, PhD
Peking University Cancer Hospital & Institute
First Submitted
May 18, 2020
First Posted
May 26, 2020
Study Start
November 9, 2020
Actual (reported)Primary Completion
September 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Endostar Treatment of Advanced Non-small Cell Lung Cancer Multi-center Clinical Research
refer to the drug label.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
The Second People's Hospital of Yangcheng County
Jincheng, Shanxi, 048100, China
Sichuan Academy of Medical Sciences· Sichuan Province People's Hospital
Chengdu, Sichuan, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Peking University Cancer Hospital
Beijing, China
Study Completion
March 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 27, 2023
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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