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

Study Overview
=================
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.

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

Conditions
-----------------
HER2 Gene Mutation, Adenocarcinoma Lung Stage IV

Intervention / Treatment
-----------------
* Drug: Poziotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Poziotinib<br>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. | Drug: Poziotinib<br>* A cycle of study treatment is defined as 28 days.<br>* Other names: NOV120101;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate; ORR including rage of CR&PR | It will be assessed on based of RECIST 1.1. | through study completion (3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, TTP | from first IP administration to date of first documented progression | through study completion (3 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pan-HER inhibitor