In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date. The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
A cycle of study treatment is defined as 28 days.
Korean Association for the Study of Targeted Therapy
Seoul, South Korea
Objective Response Rate; ORR including rage of CR&PR
It will be assessed on based of RECIST 1.1.
Time frame: through study completion (3 years)
Time to progression, TTP
from first IP administration to date of first documented progression
Time frame: through study completion (3 years)
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