Rationale: Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.
Name: gefitinib
Description: Patients will be treated with gefitinib, 250 mg p.o., dailyType: DrugGefitinib and Berberine
Name: Berberine
Description: Patients will be treated with Berberine, 50 mg p.o., tidType: DrugGefitinib and Berberine
Description: Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
Measure: Progression free survival Time: Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patientDescription: Best overall response (complete remission or partial remission) across all assessment time-points according to RECIST Criteria 1.1, during the period from enrolment to termination of trial treatment.
Measure: Objective response Time: through study completion,an average of three yearsDescription: Adverse events graded according to NCI CTCAE V4.
Measure: safety Time: Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patientSingle Group Assignment
There is one SNP
Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation Rationale: Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. --- L858R ---
- Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R) Exclusion Criteria: - Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma. --- L858R ---