Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation (Geber)
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|ClinicalTrials.gov Identifier: NCT03486496|
Recruitment Status : Unknown
Verified March 2018 by Fujian Cancer Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Adenocarcinoma EGFR Mutation||Drug: gefitinib Drug: Berberine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase II Trial of Gefitinib and Berberine in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations|
|Estimated Study Start Date :||June 5, 2018|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Gefitinib and Berberine
Experimental: Gefitinib and Berberine Patients will be treated with Gefitinib and Berberine. Gefitinib: 250 mg p.o., daily. Berberine: 50 mg p.o., tid.
Patients will be treated with gefitinib, 250 mg p.o., daily
Other Name: Iressa (AstraZeneca)
Patients will be treated with Berberine, 50 mg p.o., tid
Other Name: Berberine Sulfate
- Progression free survival [ Time Frame: Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient ]Time from the date of enrolment to discontinuation of treatment for any reason (including progression of disease, treatment toxicity, refusal and death)
- Objective response [ Time Frame: through study completion,an average of three years ]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.
- safety [ Time Frame: Within 6 months of the last visit of last patient, approximately 30 months after inclusion of first patient ]Adverse events graded according to NCI CTCAE V4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486496
|Contact: Gen Lin, Dr.||firstname.lastname@example.org|
|Fujian cancer hospital|
|Fuzhou, Fujian, China|
|Principal Investigator:||Cheng Huang, MD.||Fujian Cancer Hospital|