Status:
UNKNOWN
Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Lung Adenocarcinoma
EGFR Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
Strong lipogenic activity and high expression of sterol regulatory element-binding protein 1 (SREBP-1) were found in gefitinib-resistance NSCLC cells. Berberine, an effective suppressor of SREBP1 and ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03486496
Start Date
June 5 2018
End Date
February 1 2020
Last Update
April 3 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian cancer hospital
Fuzhou, Fujian, China