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Recruiting Phase 4 NCT04401059

Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study

Trial Parameters

Condition Carcinoma
Sponsor Tian Xie
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 744
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-11-09
Completion 2025-09-30
Interventions
Elemene plus first or third generation EGFR-TKIsFirst or third generation EGFR-TKIs

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 lung cancer.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18. 2. Histologically or cytologically confirmed advanced non-small cell lung adenocarcinoma(stage IIIB\~IV). 3. 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). 4. 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. 5. Confirmed by investigators, tumor tissue can't be surgically excised. 6. No prior exposure to elemene injectable and/or oral emulsion within one month. 7. Prior exposure to other Chinese patent medicine with similar efficacy within one month. If more than one month, pati

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