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OncoMatch/Clinical Trials/NCT04401059

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

Is NCT04401059 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Elemene plus first or third generation EGFR-TKIs and First or third generation EGFR-TKIs for carcinoma.

Phase 4RecruitingTian XieNCT04401059Data as of May 2026

Treatment: Elemene plus first or third generation EGFR-TKIs · First or third generation EGFR-TKIsThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR ex19del

EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene)

Required: EGFR L858R

EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene)

Disease stage

Required: Stage IIIB, IV

Prior therapy

Cannot have received: EGFR tyrosine kinase inhibitor combined with chemotherapy or anti-angiogenesis therapy

Exposure to First- or third-generation EGFR-TKIs combined treatment, for example, chemotherapy, anti-angiogenesis therapy

Cannot have received: elemene

Exception: no prior exposure within one month

No prior exposure to elemene injectable and/or oral emulsion within one month

Cannot have received: Chinese patent medicine with similar efficacy

Exception: if more than one month, 30-day washout period required

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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