In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy. Approximately 69 patients will be enrolled into the trial, and expected study duration is 48 months from Institutional Review Board(IRB) and Korea Ministry of Food and Drug Safety(MFDS) approval date. The study drug will be administered orally as one tablet(Gefitinib 250mg/ Erlotinib 150mg) once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug daily can be reduced according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days, and subjects will visit the site every 2 cycles(56 days).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Objective Response Rate(ORR) including rage of CR&PR
Assessed on based of RECIST 1.1.
Time frame: Through study completion (5 years)
Progression Free Survival, PFS
Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause
Time frame: Through study completion (5 years)
Overall Survival
Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause
Time frame: Through study completion (5 years)
The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)
Assessment on the base of NCI-CTCAE (version 4.03)
Time frame: Through study completion (5 years)
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Yonsei University Severance Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea