Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study
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
Tian Xie
744 participants
Nov 9, 2020
INTERVENTIONAL
Conditions
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 lung cancer.
Eligibility
Inclusion Criteria8
- 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 Criteria9
- 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.
Interventions
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.
refer to the drug label.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04401059