Status:
RECRUITING
Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study
Lead Sponsor:
Tian Xie
Collaborating Sponsors:
LinkDoc Technology (Beijing) Co. Ltd.
Conditions:
Carcinoma
Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- Age ≥ 18.
- Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB\~IV).
- Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) or third generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib) monotherapy for the first time (patients who have been using first- or third-generation EGFR-TKIs for less than 28 days can be enrolled).
- Patients positive for EGFR gene mutation (deletions in exon 19 and L858R in exon 21 of the EGFR gene), with disease progression after receiving chemotherapy can be enrolled.
- Confirmed by investigators, tumor tissue can't be surgically excised.
- No prior exposure to elemene injectable and/or oral emulsion within one month.
- Prior exposure to other Chinese patent medicine with similar efficacy within one month. If more than one month, patients can be enrolled after a 30-day washout period (without continuing to use the above medications).
- The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document.
Exclusion
- Patients with any EGFR mutations other than 19DEL or 21L858R.
- Accompanied by other active tumors. (Except for stable basal cell carcinoma after treatment， If metachronous tumors have been controlled, participating was allowed )
- Exposure to First- or third-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy.
- Receiving radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Allergic to Elemene.
- Participating in other drug clinical trials.
- Refuse to comply with the follow-up.
- The researchers did not consider it appropriate to participate in this study for other reasons.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT04401059
Start Date
November 9 2020
End Date
March 30 2026
Last Update
December 27 2023
Active Locations (7)
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1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
2
Panjin Central Hospital
Panjin, Liaoning, China
3
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
4
The Second People's Hospital of Yangcheng County
Jincheng, Shanxi, China, 048100