Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation
NCT03486496 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2018-04-03
Summary
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.
Conditions
- Lung Adenocarcinoma
- EGFR Mutation
Interventions
- DRUG
-
gefitinib
Patients will be treated with gefitinib, 250 mg p.o., daily
- DRUG
-
Berberine
Patients will be treated with Berberine, 50 mg p.o., tid
Sponsors & Collaborators
-
Fujian Cancer Hospital
lead OTHER_GOV
Principal Investigators
-
Cheng Huang, MD. · Fujian Cancer Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-06-05
- Primary Completion
- 2019-06-01
- Completion
- 2020-02-01
Countries
- China
Study Locations
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