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
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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.
Condition or disease | Intervention/treatment | Phase |
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Lung Adenocarcinoma EGFR Mutation | Drug: gefitinib Drug: Berberine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: gefitinib
Patients will be treated with gefitinib, 250 mg p.o., daily
Other Name: Iressa (AstraZeneca) Drug: Berberine 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years
- ECOG performance status 0-2
- Adequate haematological function, coagulation, liver function and renal function
- Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
- TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
- Measurable or evaluable disease (according to RECIST 1.1 criteria).
- 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.
Patients with any known significant ophthalmologic anomaly of the ocular surface
- Patients who received prior chemotherapy for metastatic disease
- Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
- Pregnancy

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. | 00861-591-83660063 | lingen197505@163.com |
China, Fujian | |
Fujian cancer hospital | |
Fuzhou, Fujian, China |
Principal Investigator: | Cheng Huang, MD. | Fujian Cancer Hospital |
Responsible Party: | Fujian Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT03486496 |
Other Study ID Numbers: |
CSWOF201801 |
First Posted: | April 3, 2018 Key Record Dates |
Last Update Posted: | April 3, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data will be available |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Data will be available within 6 months of study completion |
Access Criteria: | Data access requests will be reviewed by an external indepentent Review Panel. Requesdtors will be required to sign a Data Access Agreement. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Lung Adenocarcinoma EGFR mutation Gefitinib Berberine |
Adenocarcinoma Adenocarcinoma of Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |