RecruitingPhase 4NCT04401059

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

Sponsor

Tian Xie

Enrollment

744 participants

Start Date

Nov 9, 2020

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Carcinoma Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding a plant-based medicine called elemene (used in traditional Chinese medicine) improves outcomes for people with advanced lung cancer who are already taking targeted therapy pills (EGFR inhibitors). **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced non-small cell lung cancer (stage 3B or 4) - Your cancer has a specific genetic mutation called EGFR (exon 19 deletion or L858R) - You are starting targeted therapy pills for the first time (or have been on them less than 28 days) - Your tumor cannot be surgically removed **You may NOT be eligible if...** - Your EGFR mutation is a type other than the two listed above - You have another active cancer at the same time - You used elemene in the last month (shorter washout periods may apply) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElemene plus first or third generation EGFR-TKIs

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.

DRUGFirst or third generation EGFR-TKIs

refer to the drug label.