Carcinoma, Non-Small-Cell LungSELECT-1NCT04397432
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Retrospective Study
An observational study of Carcinoma, Non-Small-Cell Lung, run by Tian Xie at 19 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 878 participants
- Where
- 19 sitesChina
- Study dates
- 28 Aug 2020to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Accompanied by other active tumors.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Dongfang Hospital Beijing University of Chinese Medicine
Beijing, 100078
Beijing Cancer Hospital
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Cancer Hospital of Huanxing Chaoyang District Beijing
Beijing
Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital
Chengdu, Sichuan
Chongqing University Cancer Hospital
Chongqing
Hangzhou Cancer Hospital
Hangzhou, Zhejiang
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang
Zhejiang Hospital
Hangzhou, Zhejiang
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang
The Second People's Hospital of Yangcheng County
Jincheng, Shanxi
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Hangzhouwan Hospital
Ningbo, Zhejiang
Panjin Central Hospital
Panjin, Liaoning
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
Shenyang Tenth People's Hospital
Shenyang, Liaoning, 110000
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
Tianjin Medical University General Hospital
Tianjin
About this 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
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.
Read the 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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Elemene, TKI, EGFR, Real world study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elemene plus TKIs | 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 | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2021
Secondary outcomes (6)
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.
Measured: 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.
Measured: June 2021
DCR
Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
Measured: June 2021
KPS score
Performance status were measured by Karnofsky Performance Scale (KPS).
Measured: June 2021
ECOG score
Eastern Cooperative Oncology Group (ECOG) performance status adopted the zubrod-ecog-who scoring standard.
Measured: 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.
Measured: Start of treatment until 30 days after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start28 Aug 2020
- Primary completion30 Apr 2023
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 878 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tian Xie
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Sponsor-investigator, Tian Xie, Hangzhou Normal University
- Investigators
- Ziping Wang, PhD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397432
- Sponsor's protocol ID
- HangzhouNU
- Acronym
- SELECT-1
- Status last verified
- Dec 2023
- First submitted
- 18 May 2020
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04397432
- Acronym / sponsor ID
- SELECT-1 / HangzhouNU
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Elemene, TKI, EGFR, Real world study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 878 participants (actual)
- Lead sponsor
- Tian XieUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elemene plus TKIs | – | –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 | – | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Accompanied by other active tumors.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OS
Time frame: June 2021
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.
6 secondary outcomes
PFS
Time frame: June 2021
ORR
Time frame: June 2021
DCR
Time frame: June 2021
KPS score
Time frame: June 2021
ECOG score
Time frame: June 2021
Incidence and severity of AE or SAE
Time frame: Start of treatment until 30 days after the last dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziping Wang, PhD principal investigator
Peking University Cancer Hospital & Institute
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Tian Xie at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.