Status:
UNKNOWN
The Continuation of Gefitinib Treatment Beyond Progression in Non-small Cell Lung Cancer Patients With EGFR Mutation
Lead Sponsor:
Samsung Medical Center
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Although EGFR-TKIs such as gefitinib, erlotinib or afatinib are recommended as first-line therapy in patients with advanced, recurrent or metastatic nonsquamous NSCLC patients who have known active EG...
Eligibility Criteria
Inclusion
- Histologically confirmed stage IIIB/IV or recurrent NSCLC with activating EGFR mutation in exon 18 through exon 21 except T790M
- Patients who achieved complete/partial response more than 4 months or stable disease more than 6 months with first-line or second line gefitinib
- Patients who experience disease progression by RECIST 1.1 criteria
- Age ≥ 18years
- ECOG performance status of 0 to 2
- Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL, CCr ≥ 50mL/min
- Baseline adverse event of gefitinib ≤ Grade 2
- Written informed consent form
Exclusion
- Prior treatment with EGFR TKI
- Patients who required dose reduction of gefitinib
- Surgery undertaken less than 4 weeks before the study
- Localized radiotherapy unless completed more than 2 weeks before the study
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method (hormonal or barrier methods))
- Uncontrolled symptomatic brain metastasis
- Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
- Concomitant use of CYP3A4 inducers/inhibitors
- Prolonged QT interval in ECG (QTc \>450 msec)
- Patients who cannot take a medicine orally or who have a gastrointestinal absorption disorder
Key Trial Info
Start Date :
February 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03399669
Start Date
February 17 2015
End Date
December 31 2018
Last Update
January 16 2018
Active Locations (1)
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1
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710