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Report for Clinical Trial NCT03486496

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-label Phase II Trial of Gefitinib and Berberine in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations

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.

NCT03486496 Lung Adenocarcinoma EGFR Mutation
MeSH:Adenocarcinoma Adenocarcinoma of Lung

2 Interventions

Name: gefitinib

Description: Patients will be treated with gefitinib, 250 mg p.o., daily
Type: Drug
Group Labels: 1

Gefitinib and Berberine

Name: Berberine

Description: Patients will be treated with Berberine, 50 mg p.o., tid
Type: Drug
Group Labels: 1

Gefitinib and Berberine


Primary Outcomes

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 patient

Secondary Outcomes

Description: 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 years

Description: 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 patient

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

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 ---



HPO Nodes