drugset / Trial / NCT03486496

Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

NCT03486496

Phase 2 Unknown 50 enrolled Fujian Cancer Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-06-05
Primary completion
2019-06-01
Completion
2020-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Berberine Traditional medicine (herbal / TCM) 50 mg Oral
Subject Gefitinib Small molecule 250 mg Oral

Indications