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

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.

Inclusion criteria

• lung adenocarcinoma, stage IV
• Patients with HER2 mutation by sequencing

• Confirmed triple-negative patients with remnant tumor DNA
• 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

• Neutrophil count: > 1,500/uL
• Platelet count: > 100,000/uL
• Hb: > 9.0g/dL
• AST/ALT : < 2.0 x upper normal limit
• Bilirubin: < 1.25 x upper normal limit
• Serum creatinine : < upper normal limit

Exclusion criteria

• Expected lie expectancy < 3 months
• CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study)
• Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
• Patients who have histories of previous exposure to EGFR-TKI