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In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
Full description
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.
Enrollment
Sex
Volunteers
Inclusion criteria
lung adenocarcinoma, stage IV
Patients with HER2 mutation by sequencing
Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI)
ECOG performance status 0~2
Patient with at least one measurable lesions according to RECIST
Patients who have proper organ functions as follows
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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