Spots Global Cancer Trial Database for Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

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Trial Identification

Brief Title: Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)

Official Title: A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation

Study ID: NCT02979821

Conditions

HER2 Gene Mutation

Adenocarcinoma Lung Stage IV

Interventions

Poziotinib

Study Description

Brief Summary: In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.

Detailed 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.